Granted Patent
B2
US 12,458,632 · App. 19/042,453 · Granted Nov 4, 2025
Treatment of migraine
Inventors:
Mary Ann Johnson (Norristown, PA); Leonardo R. Allain (Lansdale, PA); W. Mark Eickhoff (Lansdale, PA); Craig B. Ikeda (Harleysville, PA); Chad D. Brown (Quakertown, PA); Francis J. Flanagan (North Wales, PA); Rebecca Nofsinger (Lansdale, PA); Melanie Marota (Mount Laurel, NJ); Lisa Lupton (South San Francisco, CA); Paresh B. Patel (Langhorne, PA); Hanmi Xi (Furlong, PA); Wei Xu (West Point, PA)
Assignee:
Merck Sharp & Dohme LLC
View Patent ↗
Loading inventors, assignments & file history…
Abstract
The present disclosure provides methods for the acute treatment of migraine with or without aura, comprising the administration of ubrogepant. In particular, the present disclosure provides methods for the acute treatment of migraine in patients having hepatic impairment; in patients with renal impairment; and in patients concurrently taking CYP3A4 modulators or BCRP and/or P-gp only inhibitors.
Claims (37)
1 . A rapid-release pharmaceutical tablet comprising:
(i) an amorphous compound of formula Ia:
wherein each of R b is hydrogen, and
(ii) a disintegration system,
wherein when said tablet is subjected to a dissolution test complying with USP 30 NF25 Chapt. 711, said tablet releases at least about 90% of the compound of Formula Ia contained therein in less than about 20 minutes.
2 . The tablet according to claim 1 , wherein the tablet comprises an amorphous dispersion of the compound of formula Ia.
3 . The tablet according to claim 2 , wherein the dispersion comprises a polymer matrix.
4 . The tablet according to claim 3 , wherein the polymer matrix comprises an excipient selected from polyvinylpyrrolidone-vinyl acetate copolymer and HPMCAS.
5 . The tablet according to claim 3 , wherein the dispersion comprises a dispersing agent.
6 . The tablet according to claim 1 , wherein the disintegration system comprises a disintegrant selected from croscarmellose sodium and crospovidone.
7 . The tablet according to claim 1 , wherein the disintegration system comprises sodium chloride.
8 . The tablet according to claim 3 , wherein the disintegration system comprises croscarmellose sodium and sodium chloride.
9 . The tablet according to claim 4 , wherein the disintegration system comprises croscarmellose sodium and sodium chloride.
10 . The tablet according to claim 1 , wherein the tablet further comprises at least one additional excipient selected from a diluent, a glidant, and a lubricant.
11 . The tablet according to claim 1 , wherein the tablet comprises at least one additional excipient selected from mannitol, colloidal silica, microcrystalline cellulose, and sodium stearyl fumarate.
12 . The tablet according to claim 1 , wherein the tablet achieves complete disintegration in less than about 22 minutes in a tablet disintegration test complying with USP31-NF26 Chapt. 701.
13 . The tablet according to claim 1 , wherein the tablet comprises about 50 mg of the compound of formula Ia.
14 . A rapid-release pharmaceutical tablet comprising:
(i) an amorphous compound of formula Ia:
wherein each of R b is hydrogen, and
(ii) a disintegrant,
wherein when said tablet is subjected to a dissolution test complying with USP 30 NF25 Chapt. 711, said tablet releases at least about 90% of the compound of Formula Ia contained therein in less than about 20 minutes.
15 . The tablet according to claim 14 , wherein the tablet comprises an amorphous dispersion of the compound of Formula Ia.
16 . The tablet according to claim 14 , wherein the tablet comprises a salt.
17 . The tablet according to claim 16 , wherein the salt is sodium chloride.
18 . The tablet according to claim 14 , wherein the disintegrant is selected from the group consisting of croscarmellose sodium and crospovidone.
19 . The tablet according to claim 15 , wherein (i) the dispersion comprises a polymer matrix, (ii) the disintegrant is selected from the group consisting of croscarmellose sodium and crospovidone, and (iii) the tablet further comprises sodium chloride.
20 . The tablet according to claim 14 , wherein the tablet achieves complete disintegration in less than about 22 minutes in a tablet disintegration test complying with USP31-NF26 Chapt. 701.
21 . The tablet according to claim 14 , wherein the tablet comprises about 50 mg of the compound of formula Ia.
22 . The tablet according to claim 1 , wherein the dissolution test is conducted in a paddle-stirring apparatus equipped with USP2 paddles.
23 . The tablet according to claim 22 , wherein the paddle-stirring apparatus is operated at 50 rpm.
24 . The tablet according to claim 22 , wherein the dissolution test is conducted in 900 ml of simulated gastric fluid at pH 1.8 at 37° C.
25 . The tablet according to claim 1 , wherein the dissolution test is conducted in 900 ml of simulated gastric fluid at pH 1.8 at 37° C.
26 . The tablet according to claim 14 , wherein the dissolution test is conducted in a paddle-stirring apparatus equipped with USP2 paddles.
27 . The tablet according to claim 26 , wherein the paddle-stirring apparatus is operated at 50 rpm.
28 . The tablet according to claim 26 , wherein the dissolution test is conducted in 900 ml of simulated gastric fluid at pH 1.8 at 37° C.
29 . The tablet according to claim 14 , wherein the dissolution test is conducted in 900 ml of simulated gastric fluid at pH 1.8 at 37° C.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 23, 2025
From: JOHNSON, MARY ANN; ALLAIN, LEONARDO R.; EICKHOFF, W. MARK; IKEDA, CRAIG B.; BROWN, CHAD D.; FLANAGAN, JR., FRANCIS J.; NOFSINGER, REBECCA; MAROTA, MELANIE J.; LUPTON, LISA; PATEL, PARESH B.; XI, HANMI; XU, WEI
To: MERCK SHARP & DOHME LLC
Reel/Frame 071692/0013 →
Continuity (16)
Continuation
15115026
Provisional Application
63129379
· Dec 22, 2020
Provisional Application
62087366
· Dec 4, 2014
Provisional Application
61936019
· Feb 5, 2014
References Cited (326)
US 4166452A
· Generales, Jr.
· 1979
[cited by applicant]
US 4256108A
· Theeuwes
· 1981
[cited by applicant]
US 4265874A
· Bonsen et al.
· 1981
[cited by applicant]
US 5914129A
· Mauskop
· 1999
[cited by applicant]
US 7205293B2
· Bell et al.
· 2007
[cited by applicant]
US 7390798B2
· Williams et al.
· 2008
[cited by applicant]
US 7629338B2
· Wood
· 2009
[cited by applicant]
US 7893079B2
· Wood et al.
· 2011
[cited by applicant]
US 8481556B2
· Bell et al.
· 2013
[cited by applicant]
US 8754096B2
· Bell et al.
· 2014
[cited by applicant]
US 8883807B2
· Bell et al.
· 2014
[cited by applicant]
US 8895572B2
· Burgey et al.
· 2014
[cited by applicant]
US 8912210B2
· Bell et al.
· 2014
[cited by applicant]
US 9067941B2
· Burgey et al.
· 2015
[cited by applicant]
US 9109209B2
· Cabirol et al.
· 2015
[cited by applicant]
US 9174989B2
· Chen et al.
· 2015
[cited by applicant]
US 9227972B2
· Bell et al.
· 2016
[cited by applicant]
US 9227973B2
· Bell et al.
· 2016
[cited by applicant]
US 9296750B2
· Bell et al.
· 2016
[cited by applicant]
US 9376431B2
· Xiang et al.
· 2016
[cited by applicant]
US 9409916B2
· Bell et al.
· 2016
[cited by applicant]
US 9487523B2
· Belyk et al.
· 2016
[cited by applicant]
US 9499541B2
· Bell et al.
· 2016
[cited by applicant]
US 9499545B2
· Bell et al.
· 2016
[cited by applicant]
US 9624478B2
· Cabirol et al.
· 2017
[cited by applicant]
US 9833448B2
· Bell et al.
· 2017
[cited by applicant]
US 9833488B2
· Buyuktimkin et al.
· 2017
[cited by applicant]
US 9850246B2
· Chen et al.
· 2017
[cited by applicant]
US 20040076668A1
· Berchielli et al.
· 2004
[cited by applicant]
US 20050196439A1
· Sherwood et al.
· 2005
[cited by applicant]
US 20100179166A1
· Bell et al.
· 2010
[cited by applicant]
US 20100227903A1
· Geers et al.
· 2010
[cited by applicant]
US 20120122899A1
· Bell et al.
· 2012
[cited by applicant]
US 20120122900A1
· Bell et al.
· 2012
[cited by applicant]
US 20120122911A1
· Bell et al.
· 2012
[cited by applicant]
US 20150023888A1
· Cook et al.
· 2015
[cited by applicant]
US 20160051561A1
· Etter
· 2016
[cited by applicant]
US 20160220552A1
· Mahjour et al.
· 2016
[cited by applicant]
US 20160346214A1
· Johnson et al.
· 2016
[cited by applicant]
US 20170027925A1
· Bell et al.
· 2017
[cited by applicant]
US 20170189443A1
· Parsons
· 2017
[cited by applicant]
US 20180008576A1
· Kleideiter et al.
· 2018
[cited by applicant]
US 20180092899A1
· Liu et al.
· 2018
[cited by applicant]
US 20180127417A1
· Chen et al.
· 2018
[cited by applicant]
US 20190070161A1
· Mahjour et al.
· 2019
[cited by applicant]
US 20190085061A1
· Burstein
· 2019
[cited by applicant]
US 20190135927A1
· Levin
· 2019
[cited by applicant]
US 20190209478A1
· Johnson et al.
· 2019
[cited by applicant]
US 20190374518A1
· Trugman et al.
· 2019
[cited by applicant]
US 20190374520A1
· Trugman et al.
· 2019
[cited by applicant]
US 20200383983A1
· Brin et al.
· 2020
[cited by applicant]
US 20210085612A1
· Johnson et al.
· 2021
[cited by applicant]
US 20210379029A1
· Trugman et al.
· 2021
[cited by applicant]
US 20220031686A1
· Trugman et al.
· 2022
[cited by applicant]
US 20220193051A1
· Trugman et al.
· 2022
[cited by applicant]
US 20220340650A1
· Jakate et al.
· 2022
[cited by applicant]
US 20230158128A1
· Brin et al.
· 2023
[cited by applicant]
US 20230248655A1
· Johnson et al.
· 2023
[cited by applicant]
US 20230248715A1
· Liu et al.
· 2023
[cited by applicant]
US 20230321055A1
· Trugman et al.
· 2023
[cited by applicant]
US 20230330072A1
· Trugman et al.
· 2023
[cited by applicant]
US 20240100029A1
· Trugman et al.
· 2024
[cited by applicant]
US 20240180883A1
· Trugman et al.
· 2024
[cited by applicant]
US 20240245662A1
· Trugman et al.
· 2024
[cited by applicant]
US 20240299369A1
· Trugman et al.
· 2024
[cited by applicant]
US 20240366575A1
· Trugman et al.
· 2024
[cited by applicant]
US 20250032467A1
· Boinpally et al.
· 2025
[cited by applicant]
US 20250064788A1
· Trugman et al.
· 2025
[cited by applicant]
US 20250186412A1
· Boinpally et al.
· 2025
[cited by applicant]
US 20250186422A1
· Trugman et al.
· 2025
[cited by applicant]
CN 101018781A
· 2007
[cited by applicant]
CN 101208303A
· 2008
[cited by applicant]
CN 101448821B
· 2013
[cited by applicant]
JP 2008512480A
· 2008
[cited by applicant]
JP 2008512481A
· 2008
[cited by applicant]
JP 2010529119A
· 2010
[cited by applicant]
JP 2011504481A
· 2011
[cited by applicant]
JP 2012528827A
· 2012
[cited by applicant]
KR 1020130087037A
· 2013
[cited by applicant]
RU 2216317C2
· 2003
[cited by applicant]
WO WO2004000329A1
· 2003
[cited by applicant]
WO WO2004082602A2
· 2004
[cited by applicant]
WO WO2004092166A2
· 2004
[cited by applicant]
WO WO2004092168A1
· 2004
[cited by applicant]
WO WO2006031606A2
· 2006
[cited by applicant]
WO WO2006031610A2
· 2006
[cited by applicant]
WO WO2006069754A1
· 2006
[cited by applicant]
WO WO2007092642A2
· 2007
[cited by applicant]
WO WO2007133491A1
· 2007
[cited by applicant]
WO WO2008153849A1
· 2008
[cited by applicant]
WO WO2009050234A1
· 2009
[cited by applicant]
WO WO2009065922A2
· 2009
[cited by applicant]
WO WO2009100090A1
· 2009
[cited by applicant]
WO WO2009126530A2
· 2009
[cited by applicant]
WO WO2010114801A1
· 2010
[cited by applicant]
WO WO2010139717A1
· 2010
[cited by applicant]
WO WO2011156578A1
· 2011
[cited by applicant]
WO WO2012064910A1
· 2012
[cited by applicant]
WO WO2012121758A1
· 2012
[cited by applicant]
WO WO2012122279A1
· 2012
[cited by applicant]
WO WO2015038736A2
· 2015
[cited by applicant]
WO WO2015119848A1
· 2015
[cited by applicant]
WO WO2015120014A1
· 2015
[cited by applicant]
WO WO2017051385A1
· 2017
[cited by applicant]
WO WO2019050759A1
· 2019
[cited by applicant]
WO WO2019087161A1
· 2019
[cited by applicant]
WO WO2019234709A1
· 2019
[cited by applicant]
WO WO2019234710A1
· 2019
[cited by applicant]
WO WO2020051137A1
· 2020
[cited by applicant]
WO WO2020150703A1
· 2020
[cited by applicant]
WO WO2020214906A1
· 2020
[cited by applicant]
WO WO2021062282A1
· 2021
[cited by applicant]
WO WO2021087210A1
· 2021
[cited by applicant]
WO WO2022140537A1
· 2022
[cited by applicant]
WO WO2023049920A1
· 2023
[cited by applicant]
WO WO2023173005A2
· 2023
[cited by applicant]
WO WO2024081718A1
· 2024
[cited by applicant]
“61st Annual Scientific Meeting”, American Headache Society, 208 pages, (Jul. 11-14, 2019).
[cited by applicant]
“Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling,” U.S. Food and Drug Administration (2003).
[cited by applicant]
60th Annual Scientific Meeting, American Headache Society, 60th Annual Scientific Meeting American Headache Society, AHS 2018. San Francisco, CA, United States. Jun. 28-Jul. 1, 2018.
[cited by applicant]
Ailani et al., “An optional second dose of ubrogepant is effective in achieving 2-hour pain freedom in the acute treatment of migraine (166)”, Neurology, 94(15), (2020).
[cited by applicant]
Ailani et al., “Atogepant for the Preventive Treatment of Migraine” The New England Journal of Medicine, vol. 385, No. 8, pp. 695-706 (2021).
[cited by applicant]
Allergan plc. (Nov. 5, 2015), “Allergan Outlines Open Science Model and Highlights Key Development Programs at R&D Day, Press Release.” Retrieved from the Internet: http://www/multivu.com/players/English/7671931-allerga…
[cited by applicant]
Amerge (naratriptan hydrochloride) tablets, Highlights of Prescribing Information (2016).
[cited by applicant]
American Headache Society (Jun. 9, 2016), Clinical Data Presented at American Headache Society Meeting Shows Promise of New Treatments for Migraine Prevention [Press Release]. Retrieved from the Internet: (https://ameri…
[cited by applicant]
Anonymous., “Handbook of Pharmaceutical Excipients,” 5th Edition, Pharmaceutical Press, 2006, 10 pages.
[cited by applicant]
Anonymous., “Sample Preparation of Pharmaceutical Dosage Forms,” Springer, 2011, 5 pages.
[cited by applicant]
Anonymous: “Highlights of Prescribing Information: Qulipta”, retreived online via <https://www.rxabbvie.com/pdf/qulipta_pi.pdf> (2021).
[cited by applicant]
Anonymous: “Highlights of Prescribing Information: Ubrelvy (ubrogepant) tablets,” retrieved online via <https://www.rxabbvie.com/pdf/ubrelvY-P i.pdf> (2021).
[cited by applicant]
Ansel et al., “Pharmaceutical Dosage Forms and Drug Delivery Systems”, 7th Edition, Lippincott Williams & Wilkins, 1999, pp. 367-369.
[cited by applicant]
Armstrong., “Biohaven hopes to give Allergan a headache,” Evaluate Vantage, retrieved online <https://www.evaluate.com/vantage/articles/interviews/biohaven-hopes-give-allergan-headache>: 3 pages (2018).
[cited by applicant]
Arulmozhi et al., “Migraine: Current concepts and emerging therapies”, Vascular Pharmacology, 43: 176-187 (2005).
[cited by applicant]
Ashina et al. “Plasma levels of calcitonin gene-related peptide in chronic tension-type headache,” Neurology 55.9: 1335-1340. (2000).
[cited by applicant]
Awawdeh et al. “Quantitative analysis of substance P, neurokinin A and calcitonin gene related peptide in pulp tissue from painful and healthy human teeth,” International endodontic Journal 35.1 : 30-36 (2002).
[cited by applicant]
Bagley et al., “Validating Migraine-Specific Quality of Life Questionnaire v2.1 in Episodic and Chronic Migraine,” Headache, Mar. 2012; vol. 5 2(3): pp. 409-421.
[cited by applicant]
Barbanti et al., “The role of anti-CGRP antibodies in the pathophysiology of primary headaches,” Neurol Sci 38 (Suppl. 1): pp. S31-S35 (2017).
[cited by applicant]
Beer et al. “Systemic neuropeptide levels as predictive indicators for lethal outcome in patients with postoperative sepsis,” Critical care medicine 30.8 : 1794-1798 (2002).
[cited by applicant]
Belikov., “Pharmaceutical Chemistry,” M. High School: 6 pages (1993).
[cited by applicant]
Bell et al., MEDI 20: Discovery of AGN-241689: A potent, orally-acting CGRP receptor antagonist for migraine prophylaxis, 253 American Chemical Society, Abstracts, p. 20 (Apr. 2-6, 2017) (Year: 2017).
[cited by applicant]
Bellamy et al. “Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients,” Headache: The Journal of Head and Face Pain 46.1: 24-33 (2006).
[cited by applicant]
Bennet et al. “Alleviation of mechanical and thermal allodynia by CGRP8-37 in a rodent model of chronic central pain,” Pain 86.1-2 : 163-175 (2000).
[cited by applicant]
Bigal M.E., et al., “Body mass index and episodic headaches: a population-based study,” Archives of internal medicine, Oct. 2007, vol. 167 (18), pp. 1964-1970.
[cited by applicant]
Bigal M.E., et al., “Obesity and migraine: a population study,” Neurology, 2006, vol. 66(4), pp. 545-550.
[cited by applicant]
Boinpally et al., “63rd Annual Scientific Meeting American Headache Society: Evaluation of the pharmacokinetic interaction and safety of atogepant coadministered with esomeprazole magnesium”, Headache 61 (S1): pp. 1-178…
[cited by applicant]
Boinpally et al., “Single-Dose Pharmacokinetics and Safety of Atogepant in Adults With Hepatic Impairment: Results From an Open-Label, Phase 1 Trial,” Clinical Pharmacology in Drug Development 10(7): pp. 726-733 (2021).
[cited by applicant]
Boinpally et al., “Single-Dose Pharmacokinetics and Safety of Ubrogepant in Adults With Hepatic Impairment: Results From an Open-Label, Phase 1 Trial,” Clinical Pharmacology in Drug Development, 0(0): 1-8 (2022).
[cited by applicant]
Brauser, “Phase 3 Strive and Arise Trials Show Efficacy, Safety for Erenumab in Migraine Prevention,” Medscape Medical News, 2017.
[cited by applicant]
Burstein et al. “An association between migraine and cutaneous allodynia,” Annals of neurology 47.5 614-624. (2000).
[cited by applicant]
Cady et al. “Elevated saliva calcitonin gene-related peptide levels during acute migraine predict therapeutic response to rizatriptan,” Headache: The Journal of Head and Face Pain 49.9: 1258-1266. (2009).
[cited by applicant]
Cala M.L., et al., “The Activity Impairment in Migraine Diary (AIM-D): A novel migraine-specific patient-reported outcome measure to assess functioning based on activity impairment in episodic and chronic migraine patie…
[cited by applicant]
Chedid et al., “Hepatocellular Carcinoma: Diagnosis and Operative Management,” ABCD Arq Bras Cir Dig 30(4): pp. 272-278 (2017).
[cited by applicant]
Chen et al. “Menopausal flushes and calcitonin-gene-related peptide,” The Lancet 342.8862 :p. 49.(1993).
[cited by applicant]
Cheng et al. “The concentration of inhibitor which causes 50 percent inhibition (I) of an enzymatic reaction,” Biochem. Pharmacol 22 : 3099-3108 (1973).
[cited by applicant]
CHMP Guideline, “Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function”, European Medicines Agency, 15 pages, (2015).
[cited by applicant]
Cho et al. “Development of Novel Fast-Dissolving Tacrolimus Solid Dispersion-Loaded Prolonged Release Tablet”. European Journal of Pharmaceutical Sciences. Jan. 2014 [Online], 4:1-7. (Year: 2014).
[cited by applicant]
Clinical Trial NCT02828020: Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (Achieve I), https://clinicaltrials.gov/ct2/history/NCT02828020?V_1=View#StudyPage Top (2016).
[cited by applicant]
Clinical Trial NCT02848326: Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention, https://clinicaltrials.gov/ct2/show/NCT02848326 (2016).
[cited by applicant]
Clinical Trial NCT02867709: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (Achieve II), https://clinicaltrials.gov/ct2/show/results/NCT02867709 (2016).
[cited by applicant]
Clinical Trial NCT03700320: Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine, https://clinicaltrials.gov/ct2/sho…
[cited by applicant]
Clinical Trial NCT03777059: 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine, https://www.clinicaltrials.gov/ct2/show/NCT03777059 (2018).
[cited by applicant]
Connor et al., “Randomized, controlled trial of telcagepant for the acute treatment of migraine”, Neurology, 2009, pp. 970-977, 73.
[cited by applicant]
Curto et al., “Ubrogepant for the treatment of migraine.” Expert Opinion on Pharmacotherapy 21(7) (2020): 755-759.
[cited by applicant]
Dahlof CGH. “Infrequent or non-response to oral sumatriptan does not predict response to other triptans—review of four trials,” Cephalagia, Feb. 2006, vol. 26 (2), pp. 98-106.
[cited by applicant]
Deen et al. “Blocking CGRP in migraine patients—a review of pros and cons,” The Journal of Headache and Pain 18(96): 9 pages (2017).
[cited by applicant]
Delay-Goyet et al. “Relative involvement oi substance P and CGRP mechanisms in antidromic vasodilation in the rat skin,” Acta physiologica scandinavica 146.4 : 537-538.(1992).
[cited by applicant]
Do et al., “Therapeutic novelties in migraine: new drugs, new hope?,” The Journal of Headache and Pain, 20: Article 37 pp. 1-13 (2019).
[cited by applicant]
Dodick et al., “Ubrogepant Achieves Onset of Pain Relief at 1 Hour for the Acute Treatment of Migraine (1223)”, Neurology, 94(15), (2020).
[cited by applicant]
Dodick et al., “Ubrogepant for the Acute Treatment of Migraine When Administered During the Prodrome (Premonitory Phase): Results From a Phase 3, Randomized, Double-blind, Placebo-Controlled, Crossover Study (S47. 001).…
[cited by applicant]
Dodick et al., “Ubrogepant for the treatment of migraine”, New England Journal of Medicine 381.23: 2230-2241 (2019).
[cited by applicant]
Doods “Development of CGRP antagonists for the treatment of migraine,” Current opinion in investigational Drugs 2.9: 1261-1268. (2001).
[cited by applicant]
Doods et al. “Pharmacological profile of BIBN4096BS, the first selective small molecule CGRP antaaonist,” British Journal of Pharmacology 29.3 : 420-423. (2000).
[cited by applicant]
Dos Santos et al., “Small molecule CGRP receptor antagonists for the preventive treatment of migraine: a review.” European Journal of Pharmacology 922 (2022): 174902.
[cited by applicant]
Edvinsson et al. “Characterization of the effects of a non-peptide CGRP receptor antagonist in SK-N-MC cells and isolated human cerebral arteries,” European journal of pharmacology 415. : 39-44. (2001).
[cited by applicant]
Edvinsson et al., “Basic mechanisms of migraine and its acute treatment”, Pharmacology and Therapeutics, 136: 319-333 (2012).
[cited by applicant]
Edvinsson et al., “CGRP as the target of new migrainetherapies—successful translation from bench to clinic”, Nature Reviews, 14: 338-350 (2018).
[cited by applicant]
Edvinsson et al., “Neuropeptides in Migraine and Cluster Headache Review Article”, Cephalalgia, Oct. 14, 1994 (Oct. 14, 1994), pp. 320-327, XP055542226.
[cited by applicant]
Escott et al. “Trigeminal ganglion stimulation increases facial skin blood flow in the rat: a major role for calcitonin gene-related peptide,” Brain research 669.i : 93-99 (1995).
[cited by applicant]
Evans et al. “The asymmetric synthesis of. alpha.-amino acids. Electrophilic azidation of chiralimide enolates, a practical approach to the syntheses of (R) and (S)-alpha azido carboxylic acids,” Journal of the American…
[cited by applicant]
Extended European Search Report for EP Application No. 20869848.0 dated Dec. 22, 2023.
[cited by applicant]
Fierce Biotech, “Merck kills Phill migraine drug program” (Jul. 29, 2011), available at <https://www.fiercebiotech.com/biotech/merck-kills-phiii-migraine-drug-program>.
[cited by applicant]
Food and Drug Administration, “The Impact of Renal Impairment on Patient Drug Response Assessing the Need for a Consensus Approach”, Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, (2019).
[cited by applicant]
Foster et al. “Calcitonin gene-related peptide is chemotactic for human T lymphocytes,” Annals of the New York Academy of Sciences 657.1 : 397-404. (1992).
[cited by applicant]
Friesen et al., “Hydroxypropyl Methylcellulose Acetate Succinate-Based Spray-Dried Dispersions: An Overview,” Molecular Pharmaceutics, 5(6): 1003-1019 (2008).
[cited by applicant]
Gelaye B., et al., “Body composition status and the risk of migraine: a meta-analysis,” Neurology, May 2017, vol. 88 (19), pp. 1795-1804.
[cited by applicant]
Gennaro Alfonso R., “Remington: The Science and Practice of Pharmacy”, 2000, 20th edition, Table of Contents.
[cited by applicant]
Global Health Metrics, “Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019”, The Lancet, 396 (10258), pp. 1204-1222.
[cited by applicant]
Goadsby et al. “Release of vasoactive peptides in the extracerebral circulation of humans and the cat during activation of the trigerninovascular system,” Annals of Neurology: Official Journal of the American Neurologic…
[cited by applicant]
Goadsby et al. “Vasoactive peptide release in the extracerebral circulation of humans during migraine headache,” Annals of Neurology: Official Journal of the American Neurological Association and the Child Neurology Soc…
[cited by applicant]
Goadsby et al., “Efficacy of Ubrogepant for the Treatment of Migraine Symptoms During the Prodrome (Premonitory Phase): Results From the Prodrome Trial” (2023)., Neurology, [Online] pp. 1-6.
[cited by applicant]
Goadsby et al., “Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: randomized, placebo-controlled trial in healthy adults.” Cephalalgia 39.14 (2019): 1753-1761.
[cited by applicant]
Goadsby et al., “Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trail” (2020).
[cited by applicant]
Goadsby, “Bench to bedside advances in the 21st century for primary headache disorders: migraine treatments for migraine patients,” Brain 139(10): pp. 2571-2577 (2016).
[cited by applicant]
Goodman & Gilman's The Pharmacological Basis of Therapeutics, Joel G. Hardman et al., eds., McGraw-Hill Professional, 10th ed. 2001, Table of Contents.
[cited by applicant]
Guo et al., “The Applications of Vitamin E TPGS in Drug Delivery,” European Journal of Pharmaceutical Sciences, 49(2): 175-186 (2013).
[cited by applicant]
Harmon et al. “Reaction of arylsulfonyl azides with N-methylindole,” The Journal of Organic Chemistry, 38.1, 11-16 (1973).
[cited by applicant]
Herzog et al. “CGRP receptors in the gerbil spiral modular artery mediate a sustained vasodilation via a transient cAMP-mediated Ca2+-decrease,” The Journal of membrane biology 189.3, 225-236.(2002).
[cited by applicant]
Hewitt et al., “Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine,” Cephalalgia Apr. 2011;31(6): 712-22.
[cited by applicant]
Ho et al., “Efficacy and Tolerability of MK-097 (telcagepant), a new oral antagonist of cacitonin gene-related peptide receptor, compared with zoimitriptant for acute migraine; a randomised, placebo-controlled parallel-…
[cited by applicant]
Ho et al., “Randomized Controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine”, Neurology, Apr. 15, 2008; 70 (16): 1304-12.
[cited by applicant]
Ho et al., “Randomized Controlled Trial of the CGRP receptor antagonist telcagepant for migraine prevention”, Neurology, Sep. 9, 2014; 83(11): 958-66.
[cited by applicant]
Ho et al., “Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine”, Cephalalgia, Feb. 2016;36(2): 148-61.
[cited by applicant]
Hoffman et al. “Capsaicin-sensitive nerve fibers induce epithelial cell proliferation, inflammatory cell immigration and transforming growth factor-alpha expression in the rat colonic mucosa in vivo,” Scandinavian Journ…
[cited by applicant]
Holland P.R., and Goadsby P.J., “Targeted CGRP Small Molecule Antagonists for Acute Migraine Therapy,” Neurotherapeutics, Apr. 2018, vol. 15 (2), pp. 304-312.
[cited by applicant]
Holzer et al. “Job queues and wages,” Title Quarterly Journal of Economics 106.3, 739-768. (1991).
[cited by applicant]
Holzer et al., “Evaluation o Sodium Stearyl Fumarate as a Tablet Lubricant,” International Journal of Pharmaceutics, 2(3-4): 145-153 (Abstract Only)(1979).
[cited by applicant]
Hutchinson et al., “Ubrogepant for the Acute Treatment of Migraine: Pooled Safety and Tolerability From Achieve I and Achieve II Phase 3 Studies (117)”, Neurology, 94(15), (2020).
[cited by applicant]
Imitrex (sumatriptan) tablets, Highlights of Prescribing Information (2020).
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/IB19/54780 dated Dec. 8, 2020.
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US15/13672 dated Aug. 9, 2016.
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US20/28666 dated Oct. 28, 2021.
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US21/43791 dated Nov. 18, 2021.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US23/76576 dated Feb. 23, 2024.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/IB19/54780, dated Oct. 28, 2019.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/IB19/54781 dated Oct. 22, 2019.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US11/60081, dated Dec. 19, 2011.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US15/13672 dated Apr. 21, 2015.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US20/28666 dated Aug. 28, 2020.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US20/52891 dated Feb. 17, 2021.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US21/64853 dated Mar. 18, 2022.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US22/77061 dated Jan. 4, 2023.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US23/64027 dated Sep. 26, 2023.
[cited by applicant]
Israel et al., “CGRP Monoclonal Antibodies for the Preventative Treatment of Migraine,” Current Pain and Headache Reports 22.5 (2018): 1-6.
[cited by applicant]
Jakate et al., “Effects of CYP3A4 and P-glycoprotein inhibition or induction on the pharmacokinetics of ubrogepant in healthy adults: Two phase 1, open-label, fixed-sequence, single-center, crossover trials,” Cephalalgi…
[cited by applicant]
Johnson et al., “A pharmacogenomic evaluation of migraine therapy”, Expert Opinion on Pharmacotherapy, 8: 1821-1835 (2007).
[cited by applicant]
Kasarala G. et al., “Standard Liver Tests,” Clinical Liver Disease, Jul. 2016, vol. 8 (1), pp. 13-18.
[cited by applicant]
Kibbe, “Handbook of Pharmaceuticals Excipients”, 2000, Pharmaceutical Press, XP002773202, p. 386.
[cited by applicant]
Kielbasa et al., “A new era for migraine: pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody”, Cephalalgia 39.10: 1284-1297 (2019).
[cited by applicant]
Kopruszinski et al., “Prevention of stress- or nitric oxide donor-induced medication overuse headache by a calcitonin gene-related peptide antibody in rodents,” Cephalalgia, 37(6): 560-570 (2017).
[cited by applicant]
Kristoffersen E.S., et al., “Migraine, Obesity, and Body Fat Distribution—a Population-Based Study,” The journal of headache and pain, Aug. 2020, vol. 21 (1), pp. 97.
[cited by applicant]
Lance “Headache Pathogenesis: Monoarnines,” Neuropeptides, Purines & Nitric Oxide 3-9 (1997).
[cited by applicant]
Lars Edvinsson: “CGRP as the target of new migraine therapies—successful translation from bench to clinic”, Nature Reviews, Apr. 24, 2018 (Apr. 24, 2018). XP055476796.
[cited by applicant]
Lassen et al. “CGRP may play a causative role in migraine,” Cephalalgia 22.1 (2002): 54-61.
[cited by applicant]
Late-Breaking Abstracts: 60th Annual Scientific Meeting, American Headache Society, 60th Annual Scientific Meeting American Headache Society, AHS 2018. San Francisco, CA, United States. Jun. 28-Jul. 1, 2018.
[cited by applicant]
Li et al. “Effect of CGRP receptor antagonist CGRP8-37 on nociceptive response, NOS expression and NO content in the dorsal horn of spinal cord during formalin-induced inflammatory pain in rats,” Chinese Journal of Appl…
[cited by applicant]
Lipton et al., “Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the Achieve II randomized clinical trial.” Jama 322.19: 1887-1898 (2019).
[cited by applicant]
Lipton et al., “Efficacy, safety, and tolerability of rimegepant 75 mg orally dissolving tablet for the acute treatment of migraine: Results from a phase 3, double-blind, randomized, placebo-controlled trial, Study 303”…
[cited by applicant]
Lipton et al., (Postgraduate Medicine, Minneapolis (2001) 109: 1-6)(2001).
[cited by applicant]
Lipton R.B, et al., “Impact of NSAID and Triptan Use on Developing Chronic Migraine: Results from the American Migraine Prevalence and Prevention (AMPP) Study,” Headache, Nov./Dec. 2013, vol. 53 (10), pp. 1548-1563.
[cited by applicant]
Magellan RX Management, Ubrogepant (Ubrelvy™) New Drug Update; retrieved online <https://www.hhs.texas.gov/sites/default/files/documents/about-hhs/communications-events/meetings-events/dur/may-2020/may-2020-durb-agenda-…
[cited by applicant]
May et al. “Intractable eye pain: indication for triotans,” Cephalalgia 22.3, 195-196.(2002).
[cited by applicant]
McCarthy, “Oral rimegepant increased freedom from pain and from most bothersome symptom at 2 h in acute migraine.” Annals of internal medicine 171(10) (2019): JC59.
[cited by applicant]
Medsafe, “Drug Metabolism—The Importance of Cytochrome P450 3A4”, retrieved online https://www.medsafe.govt.nz/profs/PUArticles/March2014DrugMetabolismCytochromeP4503A 4.htm (2014).
[cited by applicant]
Meglio, “Dose-Dependent Weight Reductions Observed With Atogepant”, Neurology Live, Jun. 15, 2022 . . . .
[cited by applicant]
Menard et al. “A calcitonin gene-related peptide receptor antagonist prevents the development of tolerance to spinal morphine analgesia,” Journal of Neuroscience 16. 7, 2342-2351 (1996).
[cited by applicant]
Merck, B.I. and Co Inc Harleysville PA USA et al: “Discovery of AGN-241689: A potent, orally-acting CGRP receptor antagonist for migraine prophylaxis”, Abstracts of Papers, ACS National Meeting & Exposition; 253RD Natio…
[cited by applicant]
Messali A.J., et al., “Treatment persistence and switching in triptan users: a systematic literature review,” Headache, Jul.-Aug. 2014, vol. 54 (7), pp. 1120-1130.
[cited by applicant]
Messina R., et al., “CGRP—A Target for Acute Therapy in Migraine: Clinical Data,” Cephalalgia, An International Journal of Headache, 2019, vol. 39(3), pp. 420-427.
[cited by applicant]
Molina et al. “Induction of Insulin Resistance In Vivo by Amylin and Calcitonin Gene—Related Peptide,” Diabetes 39.2, 260-265 (1990).
[cited by applicant]
Mullin et al., “Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy”, Neurology, vol. 94, No. 20, Jan. 13, 2020, pp. e2121-e2125.
[cited by applicant]
Mullin, “Acute treatment benefit from oral CGRP receptor antagonist and monoclonal antibody combination: rimegepant 75mg for acute treatment of attacks during preventive therapy with erenumab”, 61ST Annual Scientific Me…
[cited by applicant]
Mullin, “Successful gepant-monoclonal antibody combination: Rimegepant 75mg for acute treatment of attacks during preventive therapy with erenumab”, Cephalalgia Sep. 1, 2019 Sage Publications Ltd NLD, vol. 39, No. 1, Su…
[cited by applicant]
National Center for Biotechnology Information ““
[cited by applicant]
National Center for Biotechnology Information “
[cited by applicant]
Negro A., et al., “CGRP Receptor Antagonists: An Expanding Drug Class for Acute Migraine?,” Expert Opinion on Investigational Drugs, 2012, vol. 21(6), pp. 807-818.
[cited by applicant]
Negro A., et al., “Serotonin receptor agonists in the acute treatment of migraine: a review on their therapeutic potential,” Journal of Pain Research, Mar. 2018, vol. 11, pp. 515-526.
[cited by applicant]
Negro et al., “Gepants for the treatment of migraine,” Expert Opinion on Investigational Drugs 28.6 (2019): 555-567.
[cited by applicant]
Neuschwander-Tetri B.A. et al., “The upper limits of normal for serum ALT levels reported by clinical laboratories depend on local reference populations,” Arch Intern Med., Mar. 2004, vol. 168(6), pp. 663-666.
[cited by applicant]
Olesen et al. “Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine,” New England Journal of Medicine 350.11, 1104-1110. (2004).
[cited by applicant]
Ornello R., et al., “Migraine and body mass index categories: a systematic review and meta-analysis of observational studies,” The journal of headache and pain, Mar. 2015, vol. 16 (1), 14 pgs.
[cited by applicant]
Partial EP Search Report for EP Application No. 20869848.0 dated Sep. 21, 2023.
[cited by applicant]
Peterlin B.L., et al., “Obesity and migraine: the effect of age, gender and adipose tissue distribution,” Headache, Jan. 2010, vol. 50 (1), pp. 52-62.
[cited by applicant]
Petersen et al. “BIBN4096BS Antagonizes Human a-calcitonin Gene Related Peptide-C35 induced Headache and Extracerebral Artery Dilatation,” Clinical Pharmacology & Therapeutics 77.3 :202-213.(2005).
[cited by applicant]
Pitt et al., “Determination of the Tensile Strength of Elongated Tablets,” Powder Technology, 238: 169-175 (2013).
[cited by applicant]
Ramadhani et al. “Preparation and Characterisation of Kolliphor P188 and P 237 Solid Dispersion Oral Tablets Containing the Poorly Water Soluble DrugDisulfiram”. International Journal of Pharmaceutics. Sep. 2014 [Online…
[cited by applicant]
Rapoport et al., “Triptans are all Different”, Arch Neurol, 58(9):1479-1480 (2001).
[cited by applicant]
Remington J.P “Remington's Pharmaceutical Sciences,” 17th Edition Edited by Alfonso R. Gennaro, Mack Publishing Co, Journal of Pharmaceutical Science, 1985, vol. 74 (10).
[cited by applicant]
Remington, “The Science and Practice of Pharmacy”, 2000, Lippincott Williams&Wilkins, XP002773203, pp. 861-862.
[cited by applicant]
Repka et al., “Melt Extrusion: Process to Product,” Expert Opinion on Durg Delivery, Dec. 6, 2011, 9(1): 105-125.
[cited by applicant]
Reuter, “A Review of Monoclonal Antibody Therapies and Other Preventative Treatments in Migraine”, Headache, Woodbury, NJ, United States, vol. 58, Apr. 26, 2018, pp. 48-59.
[cited by applicant]
Rohrenbeck et al. “Upregulation of COX-2 and CGRP expression in resident cells of the C36 Borna disease virus-infected brain is dependent upon inflammation,” Neurobiology of disease 6.1 : 15-34.(1999).
[cited by applicant]
Rowe et al., “Handbook of Pharmaceutical Excipients”, 2000, Pharmaceutical Press, XP002773225, p. 201.
[cited by applicant]
Rowe R.C., et al., “Handbook of Pharmaceutical Excipients,” APhA Publications, 4th edition, 2003. pp. 1-6.
[cited by applicant]
Russo., “CGRP-Based Migraine Therapeutics: How Might They Work, Why So Safe, and What Next?,” ACS Pharmacology & Translational Science, 2(1): 2-8 (2019).
[cited by applicant]
Salmon et al. “Altered neuroadaptation in opiate dependence and neurogenic inflammatory nociceotion in aCGRP-deficient mice,” Nature neuroscience 4.4, : 357-358. (2001).
[cited by applicant]
Saunders , B., “Allergan 2015 R&D Day”, (Nov. 5, 2015), Powerpoint Presentation, slide 1-3 and 49-51. (Allergan plc, 2015).
[cited by applicant]
Scher A.I., et al., “Factors associated with the onset and remission of chronic daily headache in a population-based study, ” Pain, Nov. 2003, vol. 106 (1-2), pp. 81-89.
[cited by applicant]
Schini-Kerth et al. “CGRP enhances induction of NO synthase in vascular smooth muscle C38 cells via a cAMP-dependent mechanism,” American Journal of Physiology—Heart and Circulatory Physiology 267.6 : 2483-2490 (1994).
[cited by applicant]
Schuster et al., “Calcitonin Gene-Related Peptide-Targeted Therapies for Migraine and Cluster Headache: A Review,” Clinical Neuropharmacology, 40(4): 169-174 (2017).
[cited by applicant]
Schwedt et al., “Time course efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind Advance trial” Cephalgia, vol. 42, No. 1, p. 3-11 (2022).
[cited by applicant]
Scott., “Ubrogepant: First Approval,” Drugs, 80: 323-328 (2020).
[cited by applicant]
Serrano D., et al., “Effects of Switching Acute Treatment on Disability in Migraine Patients Using Triptans,” Headache, Oct. 2013, vol. 53 (9), pp. 1415-1429.
[cited by applicant]
Shaw et al., “Carprolactams as Potent CGRP Receptor Antagonists for the Treatment of Migraine”, Bioorg Med. Chem Lett, 2007, pp. 4795-4798, 17.
[cited by applicant]
Silberstein S.D., et al., “Pharmacologic treatment for episodic migraine prevention in adult,” American Academy of Neurology, Apr. 2012, vol. 78 (17), pp. 1337-1345.
[cited by applicant]
Spetz et al. “Momentary increase in plasma calcitonin gene-related peptide is involved in hot flashes in men treated with castration for carcinoma of the prostate,” The Journal of urology 166.5, 1720-1723.(2001).
[cited by applicant]
Supplementary European Search Report for EP Application No. 21850713.5 dated Jun. 26, 2024.
[cited by applicant]
Szkutnik-Fiedler et al., “Pharmacokinetics, Pharmacodynamics and Drug-Drug Interactions of New Anti-Migraine Drugs-Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies,” Pharmac…
[cited by applicant]
Talal et al., “Assessment of hepatic impairment and implications for pharmacokinetics of substance use treatment”, Clinical pharmacology in drug development 6.2: 206-212 (2017).
[cited by applicant]
Tepper et al., “Erenumab in chronic migraine with medication overuse” Neurology, 92(20): e2309-2320 (2019).
[cited by applicant]
Tepper et al., “Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial,” The Lancet Neurology, 16(6): 425-434 (2017).
[cited by applicant]
Tepper, “Anti-Calcitonin Gene-Related Peptide (CGRP) Therapies: Update on a Previous Review After the American Headache Society 60th Scientific Meeting, San Francisco, Jun. 11, 2018, ” Headache 58.7 (2018): 276-290.
[cited by applicant]
Tepper, “CGRP and headache: a brief review”, Neurological Sciences (Testo Stampato), Springer Verlag, Milan, IT, vol. 40, No. 1, Mar. 5, 2019, pp. 99-105.
[cited by applicant]
Viana M., et al., “Triptan non-responders: do they exist and who are they?,” Cephalalgia, Aug. 2013, vol. 33 (11 ), pp. 891-896.
[cited by applicant]
Voss et al., “A phase Ilb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine,” Cephalalgia, 36(9): 887-898 (2016).
[cited by applicant]
Walker et al. “Mice lacking the neuropeptide a-calcitonin gene-related peptide are protected against diet-induced obesity,” Endocrinology 151.9 : 4257-4269. (2010).
[cited by applicant]
Wallengren “Dual effects of CGRP-antagonist on allergic contact dermatitis in human skin.” Contact dermatitis 43.3, : ⋅ 137-143 (2000).
[cited by applicant]
Williamson et al. ““The CGRP Family: Calcitonin Gene-Related Peptide (CGRP), Amylin, and Adrenomedullin, Landes,”” Bioscience 245-247.(2000).
[cited by applicant]
Williamson et al. “Sumatriptan inhibits neurogenic vasodilation of dural blood vessels in the anaesthetized rat-intravital microscope studies,” Cephalalaia 17.4 : 525-531 (1997).
[cited by applicant]
Winter A.C. “Body mass index, migraine, migraine frequency and migraine features in women,” Cephalalgia, Feb. 2009, vol. 29(2), pp. 269-278.
[cited by applicant]
Wu et al., “Regulatory perspectives of Type II prodrug development and time-dependent toxicity management: Nonclinical Pharm/Tox analysis and the role of comparative toxicology,” Toxicology 236(1-2): pp. 1-6 (2007).
[cited by applicant]
Yang M., et al., “Validation of the Headache Impact Test (HIT-6™) Across Episodic and Chronic Migraine,” Cephalalgia, Feb. 2011; vol. 31(3), pp. 357-367.
[cited by applicant]
Yoshida et al. “Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5.” Clinical Pharmacology & Therapeutics 100.1 (2016): 75-87.
[cited by applicant]
Yu et al. “Effects of calcitonin gene-related peptide-(8-37) on withdrawal responses in rats with inflammation,” European journal of pharmacology 347.2-3, 275-282. (1998).
[cited by applicant]
Yuan et al., “CGRP therapeutics for the treatment of migraine—a narrative review.” Ann Head Med 1 (2020): 1-22.
[cited by applicant]
Zhang et al. “Arthritic calcitonin/a calcitonin gene-related peptide knockout mice have reduced nociceptive hypersensitivity,” Pain 89.2-3,: 265-273. (2001).
[cited by applicant]
Zheng et al. “Severity of neurological signs and degree of inflammatory lesions in the brains of rats with Borna disease correlate with the induction of nitric oxide synthase,” Journal of Virology 67.10, 5786-5791. (199…
[cited by applicant]
Boinpally et al., “Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate,” Cephalalgia, vol. 41, No. 1 (Supplemental), pp. 267-268, Abstract No. P0474 (2021).
[cited by applicant]
Cited By (2)