IP Library Granted Patent US 12,263,161
Granted Patent B2
US 12,263,161 · App. 18/415,196 · Granted Apr 1, 2025

Bupropion dosage forms with reduced food and alcohol dosing effects

Inventor: Herriot Tabuteau (New York, NY)
Assignee: ANTECIP BIOVENTURES II LLC
A61K31/485A61K9/2027A61K9/2086A61K31/138
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Quick Facts
Patent No.
US 12,263,161
App. No.
18/415,196
Granted
Apr 1, 2025
Kind
B2
Abstract

This disclosure relates to dosage forms comprising bupropion hydrochloride, another salt form of bupropion, or the free base form of bupropion; dextromethorphan hydrobromide, another salt form of dextromethorphan, or the free base form of dextromethorphan, and a polymer. In some embodiments, the dosage form has no significant dose dumping of bupropion in the presence of ethanol in vitro. In some embodiments, the dosage form does not have a food effect for bupropion or dextromethorphan when taken with a high-fat meal in human subjects. Some embodiments include a method of treating a nervous system condition (such as depression, e.g., major depressive disorder, including treatment-resistant depression, agitation associated with Alzheimer's disease (or agitation associated with dementia of the Alzheimer's type), agitation associated with dementia, anxiety (or generalized anxiety disorder), neuropathic pain, or peripheral diabetic neuropathic pain) comprising, administering a dosage form described herein to a human being in need thereof.

Claims (24)

1. A method of treating agitation associated with Alzheimer's disease in a human patient who is consuming alcohol, comprising administering, twice a day, a dosage form to a human patient for the treatment of agitation associated with the patient's Alzheimer's disease, and reducing but not discontinuing consumption of alcohol by the human patient, wherein the dosage form comprises 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and a polymer.

2. The method of claim 1 , wherein the human patient is an adult male, and the human patient consumes two servings or less of alcohol per day.

3. The method of claim 1 , wherein the human patient is an adult female, and the human patient consumes one serving or less of alcohol per day.

4. The method of claim 1 , wherein the dosage form further comprises: colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, red iron oxide, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, or yellow iron oxide, or a combination thereof.

5. The method of claim 1 , wherein the polymer is a carbomer homopolymer.

6. A method of treating agitation associated with Alzheimer's disease in a human patient who is consuming alcohol, comprising administering, twice a day, a dosage form to a human patient for the treatment of agitation associated with the patient's Alzheimer's disease, and minimizing but not discontinuing consumption of alcohol by the human patient, wherein the dosage form comprises 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and a polymer.

7. The method of claim 6 , wherein the dosage form further comprises: colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, red iron oxide, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, or yellow iron oxide, or a combination thereof.

8. The method of claim 6 , wherein the human patient is an adult male, and the human patient consumes two servings or less of alcohol per day.

9. The method of claim 6 , wherein the human patient is an adult female, and the human patient consumes one serving or less of alcohol per day.

10. The method of claim 6 , wherein the polymer is a carbomer homopolymer.

11. A method of treating agitation associated with Alzheimer's disease in an adult human patient who is consuming alcohol, comprising administering, twice a day, a dosage form to a human patient for the treatment of agitation associated with the patient's Alzheimer's disease, wherein the dosage form comprises 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and a polymer,

wherein if the human patient is a male, the human patient is consuming two servings or less of alcohol per day; and

if the human patient is a female, the human patient is consuming one serving or less of alcohol per day.

12. The method of claim 11 , wherein the dosage form further comprises colloidal silicon dioxide.

13. The method of claim 11 , wherein the dosage form further comprises crospovidone.

14. The method of claim 11 , wherein the dosage form further comprises glyceryl monocaprylocaprate.

15. The method of claim 11 , wherein the dosage form further comprises L-cysteine hydrochloride monohydrate.

16. The method of claim 11 , wherein the dosage form further comprises magnesium stearate.

17. The method of claim 11 , wherein the dosage form further comprises microcrystalline cellulose.

18. The method of claim 11 , wherein the dosage form further comprises polyvinyl alcohol.

19. The method of claim 11 , wherein the dosage form further comprises sodium lauryl sulfate.

20. The method of claim 11 , wherein the dosage form further comprises stearic acid.

21. The method of claim 11 , wherein the dosage form further comprises titanium dioxide.

22. The method of claim 11 , wherein the polymer is a carbomer homopolymer.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2024
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 067487/0445 →
Continuity (6)
Continuation 18353323 · Jul 17, 2023
Continuation 18157393 · Jan 20, 2023
Provisional Application 63370771 · Aug 8, 2022
Provisional Application 63370590 · Aug 5, 2022
Provisional Application 63357521 · Jun 30, 2022
Related Publication 20240148719A1 · May 9, 2024
References Cited (400)
US 5358970A · Ruff et al. · 1994 [cited by applicant]
US 5731000A · Ruff et al. · 1998 [cited by applicant]
US 5763493A · Ruff et al. · 1998 [cited by applicant]
US 6306436B1 · Chungi et al. · 2001 [cited by applicant]
US 6780871B2 · Glick et al. · 2004 [cited by applicant]
US 8088786B2 · Mckinney et al. · 2012 [cited by applicant]
US 8569328B1 · Tabuteau · 2013 [cited by applicant]
US 9168234B2 · Tabuteau · 2015 [cited by applicant]
US 9198905B2 · Tabuteau · 2015 [cited by applicant]
US 9205083B2 · Tabuteau · 2015 [cited by applicant]
US 9238032B2 · Tabuteau · 2016 [cited by applicant]
US 9278095B2 · Tabuteau · 2016 [cited by applicant]
US 9314462B2 · Tabuteau · 2016 [cited by applicant]
US 9370513B2 · Tabuteau · 2016 [cited by applicant]
US 9375429B2 · Tabuteau · 2016 [cited by applicant]
US 9402843B2 · Tabuteau · 2016 [cited by applicant]
US 9402844B2 · Tabuteau · 2016 [cited by applicant]
US 9408815B2 · Tabuteau · 2016 [cited by applicant]
US 9421176B1 · Tabuteau · 2016 [cited by applicant]
US 9457023B1 · Tabuteau · 2016 [cited by applicant]
US 9457025B2 · Tabuteau · 2016 [cited by applicant]
US 9474731B1 · Tabuteau · 2016 [cited by applicant]
US 9486450B2 · Tabuteau · 2016 [cited by applicant]
US 9700528B2 · Tabuteau · 2017 [cited by applicant]
US 9700553B2 · Tabuteau · 2017 [cited by applicant]
US 9707191B2 · Tabuteau · 2017 [cited by applicant]
US 9763932B2 · Tabuteau · 2017 [cited by applicant]
US 9861595B2 · Tabuteau · 2018 [cited by applicant]
US 9867819B2 · Tabuteau · 2018 [cited by applicant]
US 9968568B2 · Tabuteau · 2018 [cited by applicant]
US 10058518B2 · Tabuteau · 2018 [cited by applicant]
US 10064857B2 · Tabuteau · 2018 [cited by applicant]
US 10080727B2 · Tabuteau · 2018 [cited by applicant]
US 10092560B2 · Tabuteau · 2018 [cited by applicant]
US 10092561B2 · Tabuteau · 2018 [cited by applicant]
US 10105327B2 · Tabuteau · 2018 [cited by applicant]
US 10105361B2 · Tabuteau · 2018 [cited by applicant]
US 10251879B2 · Tabuteau · 2019 [cited by applicant]
US 10463634B2 · Tabuteau · 2019 [cited by applicant]
US 10512643B2 · Tabuteau · 2019 [cited by applicant]
US 10548857B2 · Tabuteau · 2020 [cited by applicant]
US 10596167B2 · Tabuteau · 2020 [cited by applicant]
US 10688066B2 · Tabuteau · 2020 [cited by applicant]
US 10695304B2 · Tabuteau · 2020 [cited by applicant]
US 10772850B2 · Tabuteau · 2020 [cited by applicant]
US 10780064B2 · Tabuteau · 2020 [cited by applicant]
US 10780066B2 · Tabuteau · 2020 [cited by applicant]
US 10786469B2 · Tabuteau · 2020 [cited by applicant]
US 10786496B2 · Tabuteau · 2020 [cited by applicant]
US 10799497B2 · Tabuteau · 2020 [cited by applicant]
US 10806710B2 · Tabuteau · 2020 [cited by applicant]
US 10813924B2 · Tabuteau · 2020 [cited by applicant]
US 10864209B2 · Tabuteau · 2020 [cited by applicant]
US 10874663B2 · Tabuteau · 2020 [cited by applicant]
US 10874664B2 · Tabuteau · 2020 [cited by applicant]
US 10874665B2 · Tabuteau · 2020 [cited by applicant]
US 10881624B2 · Tabuteau · 2021 [cited by applicant]
US 10881657B2 · Tabuteau · 2021 [cited by applicant]
US 10894046B2 · Tabuteau · 2021 [cited by applicant]
US 10894047B2 · Tabuteau · 2021 [cited by applicant]
US 10898453B2 · Tabuteau · 2021 [cited by applicant]
US 10925842B2 · Tabuteau · 2021 [cited by applicant]
US 10933034B2 · Tabuteau · 2021 [cited by applicant]
US 10940124B2 · Tabuteau · 2021 [cited by applicant]
US 10945973B2 · Tabuteau · 2021 [cited by applicant]
US 10966941B2 · Tabuteau · 2021 [cited by applicant]
US 10966942B2 · Tabuteau · 2021 [cited by applicant]
US 10966974B2 · Tabuteau · 2021 [cited by applicant]
US 10980800B2 · Tabuteau · 2021 [cited by applicant]
US 11007189B2 · Tabuteau · 2021 [cited by applicant]
US 11020389B2 · Tabuteau · 2021 [cited by applicant]
US 11058648B2 · Tabuteau · 2021 [cited by applicant]
US 11065248B2 · Tabuteau · 2021 [cited by applicant]
US 11090300B2 · Tabuteau · 2021 [cited by applicant]
US 11096937B2 · Tabuteau · 2021 [cited by applicant]
US 11123343B2 · Tabuteau · 2021 [cited by applicant]
US 11123344B2 · Tabuteau · 2021 [cited by applicant]
US 11129826B2 · Tabuteau · 2021 [cited by applicant]
US 11141388B2 · Tabuteau · 2021 [cited by applicant]
US 11141416B2 · Tabuteau · 2021 [cited by applicant]
US 11147808B2 · Tabuteau · 2021 [cited by applicant]
US 11185515B2 · Tabuteau · 2021 [cited by applicant]
US 11191739B2 · Tabuteau · 2021 [cited by applicant]
US 11197839B2 · Tabuteau · 2021 [cited by applicant]
US 11207281B2 · Tabuteau · 2021 [cited by applicant]
US 11213521B2 · Tabuteau · 2022 [cited by applicant]
US 11229640B2 · Tabuteau · 2022 [cited by applicant]
US 11234946B2 · Tabuteau · 2022 [cited by applicant]
US 11253491B2 · Tabuteau · 2022 [cited by applicant]
US 11253492B2 · Tabuteau · 2022 [cited by applicant]
US 11273133B2 · Tabuteau · 2022 [cited by applicant]
US 11273134B2 · Tabuteau · 2022 [cited by applicant]
US 11285118B2 · Tabuteau · 2022 [cited by applicant]
US 11285146B2 · Tabuteau · 2022 [cited by applicant]
US 11291638B2 · Tabuteau · 2022 [cited by applicant]
US 11291665B2 · Tabuteau · 2022 [cited by applicant]
US 11298351B2 · Tabuteau · 2022 [cited by applicant]
US 11298352B2 · Tabuteau · 2022 [cited by applicant]
US 11311534B2 · Tabuteau · 2022 [cited by applicant]
US 11344544B2 · Tabuteau · 2022 [cited by applicant]
US 11357744B2 · Tabuteau · 2022 [cited by applicant]
US 11364233B2 · Tabuteau · 2022 [cited by applicant]
US 11382874B2 · Tabuteau · 2022 [cited by applicant]
US 11419867B2 · Tabuteau · 2022 [cited by applicant]
US 11426370B2 · Tabuteau · 2022 [cited by applicant]
US 11426401B2 · Tabuteau · 2022 [cited by applicant]
US 11433067B2 · Tabuteau · 2022 [cited by applicant]
US 11439636B1 · Tabuteau · 2022 [cited by applicant]
US 11478468B2 · Tabuteau · 2022 [cited by applicant]
US 11497721B2 · Tabuteau · 2022 [cited by applicant]
US 11510918B2 · Tabuteau · 2022 [cited by applicant]
US 11517542B2 · Tabuteau · 2022 [cited by applicant]
US 11517543B2 · Tabuteau · 2022 [cited by applicant]
US 11517544B2 · Tabuteau · 2022 [cited by applicant]
US 11524007B2 · Tabuteau · 2022 [cited by applicant]
US 11524008B2 · Tabuteau · 2022 [cited by applicant]
US 11534414B2 · Tabuteau · 2022 [cited by applicant]
US 11541021B2 · Tabuteau · 2023 [cited by applicant]
US 11541048B2 · Tabuteau · 2023 [cited by applicant]
US 11571399B2 · Tabuteau · 2023 [cited by applicant]
US 11571417B2 · Tabuteau · 2023 [cited by applicant]
US 11576877B2 · Tabuteau · 2023 [cited by applicant]
US 11576909B2 · Tabuteau · 2023 [cited by applicant]
US 11590124B2 · Tabuteau · 2023 [cited by applicant]
US 11596627B2 · Tabuteau · 2023 [cited by applicant]
US 11617728B2 · Tabuteau · 2023 [cited by applicant]
US 11617747B2 · Tabuteau · 2023 [cited by applicant]
US 11628149B2 · Tabuteau · 2023 [cited by applicant]
US 11660273B2 · Tabuteau · 2023 [cited by applicant]
US 11660274B2 · Tabuteau · 2023 [cited by applicant]
US 11717518B1 · Tabuteau · 2023 [cited by applicant]
US 11730706B1 · Tabuteau · 2023 [cited by applicant]
US 11752144B1 · Tabuteau · 2023 [cited by applicant]
US 11779579B2 · Tabuteau · 2023 [cited by applicant]
US 11839612B1 · Tabuteau · 2023 [cited by applicant]
US 11844797B1 · Tabuteau · 2023 [cited by applicant]
US 11883373B1 · Tabuteau · 2024 [cited by applicant]
US 11896563B2 · Tabuteau · 2024 [cited by applicant]
US 11925636B2 · Tabuteau · 2024 [cited by applicant]
US 11969421B2 · Tabuteau · 2024 [cited by applicant]
US 11986444B2 · Tabuteau · 2024 [cited by applicant]
US 12036191B1 · Tabuteau · 2024 [cited by applicant]
US 12042473B2 · Tabuteau · 2024 [cited by applicant]
US 12109178B2 · Tabuteau · 2024 [cited by applicant]
US 20020035105A1 · Caruso · 2002 [cited by applicant]
US 20030044462A1 · Subramanian et al. · 2003 [cited by applicant]
US 20080044462A1 · Trumbore et al. · 2008 [cited by applicant]
US 20100040679A1 · Chang · 2010 [cited by applicant]
US 20100291225A1 · Fanda et al. · 2010 [cited by applicant]
US 20150126541A1 · Tabuteau · 2015 [cited by applicant]
US 20150126542A1 · Tabuteau · 2015 [cited by applicant]
US 20150126543A1 · Tabuteau · 2015 [cited by applicant]
US 20150126544A1 · Tabuteau · 2015 [cited by applicant]
US 20150133485A1 · Tabuteau · 2015 [cited by applicant]
US 20150133486A1 · Tabuteau · 2015 [cited by applicant]
US 20150150830A1 · Tabuteau · 2015 [cited by applicant]
US 20150157582A1 · Tabuteau · 2015 [cited by applicant]
US 20150342947A1 · Pollard et al. · 2015 [cited by applicant]
US 20160008352A1 · Tabuteau · 2016 [cited by applicant]
US 20160030420A1 · Tabuteau · 2016 [cited by applicant]
US 20160030421A1 · Tabuteau · 2016 [cited by applicant]
US 20160128944A1 · Chawrai et al. · 2016 [cited by applicant]
US 20160128998A1 · Tabuteau · 2016 [cited by applicant]
US 20160136155A1 · Tabuteau · 2016 [cited by applicant]
US 20160199321A1 · Tabuteau · 2016 [cited by applicant]
US 20160228390A1 · Tabuteau · 2016 [cited by applicant]
US 20160263099A1 · Tabuteau · 2016 [cited by applicant]
US 20160263100A1 · Tabuteau · 2016 [cited by applicant]
US 20160317475A1 · Tabuteau · 2016 [cited by applicant]
US 20160317476A1 · Tabuteau · 2016 [cited by applicant]
US 20160324807A1 · Tabuteau · 2016 [cited by applicant]
US 20160339017A1 · Tabuteau · 2016 [cited by applicant]
US 20160346276A1 · Tabuteau · 2016 [cited by applicant]
US 20160361305A1 · Tabuteau · 2016 [cited by applicant]
US 20160375008A1 · Tabuteau · 2016 [cited by applicant]
US 20160375012A1 · Tabuteau · 2016 [cited by applicant]
US 20170007558A1 · Tabuteau · 2017 [cited by applicant]
US 20170014357A1 · Tabuteau · 2017 [cited by applicant]
US 20170252309A1 · Tabuteau · 2017 [cited by applicant]
US 20170281617A1 · Tabuteau · 2017 [cited by applicant]
US 20170304229A1 · Tabuteau · 2017 [cited by applicant]
US 20170304230A1 · Tabuteau · 2017 [cited by applicant]
US 20170304298A1 · Tabuteau · 2017 [cited by applicant]
US 20170354619A1 · Tabuteau · 2017 [cited by applicant]
US 20170360773A1 · Tabuteau · 2017 [cited by applicant]
US 20170360774A1 · Tabuteau · 2017 [cited by applicant]
US 20170360776A1 · Tabuteau · 2017 [cited by applicant]
US 20180092906A1 · Tabuteau · 2018 [cited by applicant]
US 20180116980A1 · Tabuteau · 2018 [cited by applicant]
US 20180133195A1 · Tabuteau · 2018 [cited by applicant]
US 20180207151A1 · Tabuteau · 2018 [cited by applicant]
US 20180256518A1 · Tabuteau · 2018 [cited by applicant]
US 20180360823A1 · Tabuteau · 2018 [cited by applicant]
US 20190000835A1 · Tabuteau · 2019 [cited by applicant]
US 20190008800A1 · Tabuteau · 2019 [cited by applicant]
US 20190008801A1 · Tabuteau · 2019 [cited by applicant]
US 20190008805A1 · Tabuteau · 2019 [cited by applicant]
US 20190015407A1 · Tabuteau · 2019 [cited by applicant]
US 20190083426A1 · Tabuteau · 2019 [cited by applicant]
US 20190142768A1 · Tabuteau · 2019 [cited by applicant]
US 20190192450A1 · Tabuteau · 2019 [cited by applicant]
US 20190192507A1 · Tabuteau · 2019 [cited by applicant]
US 20190216798A1 · Tabuteau · 2019 [cited by applicant]
US 20190216800A1 · Tabuteau · 2019 [cited by applicant]
US 20190216801A1 · Tabuteau · 2019 [cited by applicant]
US 20190290601A1 · Tabuteau · 2019 [cited by examiner]
US 20200022929A1 · Tabuteau · 2020 [cited by applicant]
US 20200093762A1 · Tabuteau · 2020 [cited by applicant]
US 20200147008A1 · Tabuteau · 2020 [cited by applicant]
US 20200147075A1 · Tabuteau · 2020 [cited by applicant]
US 20200206217A1 · Tabuteau · 2020 [cited by applicant]
US 20200215055A1 · Tabuteau · 2020 [cited by applicant]
US 20200215056A1 · Tabuteau · 2020 [cited by applicant]
US 20200215057A1 · Tabuteau · 2020 [cited by applicant]
US 20200215058A1 · Tabuteau · 2020 [cited by applicant]
US 20200215059A1 · Tabuteau · 2020 [cited by applicant]
US 20200222389A1 · Tabuteau · 2020 [cited by applicant]
US 20200230078A1 · Tabuteau · 2020 [cited by applicant]
US 20200230129A1 · Tabuteau · 2020 [cited by applicant]
US 20200230130A1 · Tabuteau · 2020 [cited by applicant]
US 20200230131A1 · Tabuteau · 2020 [cited by applicant]
US 20200237751A1 · Tabuteau · 2020 [cited by applicant]
US 20200237752A1 · Tabuteau · 2020 [cited by applicant]
US 20200246280A1 · Tabuteau · 2020 [cited by applicant]
US 20200261431A1 · Tabuteau · 2020 [cited by applicant]
US 20200297666A1 · Tabuteau · 2020 [cited by applicant]
US 20200338022A1 · Tabuteau · 2020 [cited by applicant]
US 20200360310A1 · Tabuteau · 2020 [cited by applicant]
US 20200397723A1 · Tabuteau · 2020 [cited by applicant]
US 20200397724A1 · Tabuteau · 2020 [cited by applicant]
US 20200405664A1 · Tabuteau · 2020 [cited by applicant]
US 20210000763A1 · Tabuteau · 2021 [cited by applicant]
US 20210000764A1 · Tabuteau · 2021 [cited by applicant]
US 20210000765A1 · Tabuteau · 2021 [cited by applicant]
US 20210000768A1 · Tabuteau · 2021 [cited by applicant]
US 20210000820A1 · Tabuteau · 2021 [cited by applicant]
US 20210015768A1 · Tabuteau · 2021 [cited by applicant]
US 20210015814A1 · Tabuteau · 2021 [cited by applicant]
US 20210015815A1 · Tabuteau · 2021 [cited by applicant]
US 20210023075A1 · Tabuteau · 2021 [cited by applicant]
US 20210023076A1 · Tabuteau · 2021 [cited by applicant]
US 20210030747A1 · Tabuteau · 2021 [cited by applicant]
US 20210030749A1 · Tabuteau · 2021 [cited by applicant]
US 20210030750A1 · Tabuteau · 2021 [cited by applicant]
US 20210030751A1 · Tabuteau · 2021 [cited by applicant]
US 20210046067A1 · Tabuteau · 2021 [cited by applicant]
US 20210052521A1 · Tabuteau · 2021 [cited by applicant]
US 20210060004A1 · Tabuteau · 2021 [cited by applicant]
US 20210060005A1 · Tabuteau · 2021 [cited by applicant]
US 20210069125A1 · Tabuteau · 2021 [cited by applicant]
US 20210069128A1 · Tabuteau · 2021 [cited by applicant]
US 20210077428A1 · Tabuteau · 2021 [cited by applicant]
US 20210077429A1 · Tabuteau · 2021 [cited by applicant]
US 20210077483A1 · Tabuteau · 2021 [cited by applicant]
US 20210106546A1 · Tabuteau · 2021 [cited by applicant]
US 20210177834A1 · Tabuteau · 2021 [cited by applicant]
US 20210186899A1 · Tabuteau · 2021 [cited by applicant]
US 20210186900A1 · Tabuteau · 2021 [cited by applicant]
US 20210186901A1 · Tabuteau · 2021 [cited by applicant]
US 20210186955A1 · Tabuteau · 2021 [cited by applicant]
US 20210186956A1 · Tabuteau · 2021 [cited by applicant]
US 20210196704A1 · Tabuteau · 2021 [cited by applicant]
US 20210196705A1 · Tabuteau · 2021 [cited by applicant]
US 20210205239A1 · Tabuteau · 2021 [cited by applicant]
US 20210205240A1 · Tabuteau · 2021 [cited by applicant]
US 20210205297A1 · Tabuteau · 2021 [cited by applicant]
US 20210220293A1 · Tabuteau · 2021 [cited by applicant]
US 20210220294A1 · Tabuteau · 2021 [cited by applicant]
US 20210220348A1 · Tabuteau · 2021 [cited by applicant]
US 20210260054A1 · Tabuteau · 2021 [cited by applicant]
US 20210267967A1 · Tabuteau · 2021 [cited by applicant]
US 20210338605A1 · Tabuteau · 2021 [cited by applicant]
US 20210346370A1 · Tabuteau · 2021 [cited by applicant]
US 20210361645A1 · Tabuteau · 2021 [cited by applicant]
US 20210401828A1 · Tabuteau · 2021 [cited by applicant]
US 20210401829A1 · Tabuteau · 2021 [cited by applicant]
US 20210401830A1 · Tabuteau · 2021 [cited by applicant]
US 20210401831A1 · Tabuteau · 2021 [cited by applicant]
US 20220008363A1 · Tabuteau · 2022 [cited by applicant]
US 20220071930A1 · Tabuteau · 2022 [cited by applicant]
US 20220071931A1 · Tabuteau · 2022 [cited by applicant]
US 20220079892A1 · Tabuteau · 2022 [cited by applicant]
US 20220096462A1 · Tabuteau · 2022 [cited by applicant]
US 20220105086A1 · Tabuteau · 2022 [cited by applicant]
US 20220133655A1 · Tabuteau · 2022 [cited by applicant]
US 20220142950A1 · Tabuteau · 2022 [cited by applicant]
US 20220193012A1 · Tabuteau · 2022 [cited by applicant]
US 20220218631A1 · Tabuteau · 2022 [cited by applicant]
US 20220218698A1 · Tabuteau · 2022 [cited by applicant]
US 20220233470A1 · Tabuteau · 2022 [cited by applicant]
US 20220233474A1 · Tabuteau · 2022 [cited by applicant]
US 20220233518A1 · Tabuteau · 2022 [cited by applicant]
US 20220233519A1 · Tabuteau · 2022 [cited by applicant]
US 20220241220A1 · Tabuteau · 2022 [cited by applicant]
US 20220241221A1 · Tabuteau · 2022 [cited by applicant]
US 20220241269A1 · Tabuteau · 2022 [cited by applicant]
US 20220241270A1 · Tabuteau · 2022 [cited by applicant]
US 20220265639A1 · Tabuteau · 2022 [cited by applicant]
US 20220280504A1 · Tabuteau · 2022 [cited by applicant]
US 20220313689A1 · Tabuteau · 2022 [cited by applicant]
US 20220323381A1 · Tabuteau · 2022 [cited by applicant]
US 20220378779A1 · Tabuteau · 2022 [cited by applicant]
US 20230045675A1 · Tabuteau · 2023 [cited by applicant]
US 20230096437A1 · Tabuteau · 2023 [cited by applicant]
US 20230099206A1 · Tabuteau · 2023 [cited by applicant]
US 20230100008A1 · Tabuteau · 2023 [cited by applicant]
US 20230100913A1 · Tabuteau · 2023 [cited by applicant]
US 20230114111A1 · Tabuteau · 2023 [cited by applicant]
US 20230131854A1 · Tabuteau · 2023 [cited by applicant]
US 20230142244A1 · Tabuteau · 2023 [cited by applicant]
US 20230210843A1 · Tabuteau · 2023 [cited by applicant]
US 20230218550A1 · Tabuteau · 2023 [cited by applicant]
US 20230225995A1 · Tabuteau · 2023 [cited by applicant]
US 20230233491A1 · Tabuteau · 2023 [cited by applicant]
US 20230241010A1 · Tabuteau · 2023 [cited by applicant]
US 20230248668A1 · Tabuteau · 2023 [cited by applicant]
US 20230248669A1 · Tabuteau · 2023 [cited by applicant]
US 20230255905A1 · Tabuteau · 2023 [cited by applicant]
US 20230263750A1 · Tabuteau · 2023 [cited by applicant]
US 20230270740A1 · Tabuteau · 2023 [cited by applicant]
US 20230277478A1 · Tabuteau · 2023 [cited by applicant]
US 20230277479A1 · Tabuteau · 2023 [cited by applicant]
US 20230277480A1 · Tabuteau · 2023 [cited by applicant]
US 20230277481A1 · Tabuteau · 2023 [cited by applicant]
US 20230293456A1 · Tabuteau · 2023 [cited by applicant]
US 20240000770A1 · Tabuteau · 2024 [cited by applicant]
US 20240016797A1 · Tabuteau · 2024 [cited by applicant]
US 20240024309A1 · Tabuteau · 2024 [cited by applicant]
US 20240041862A1 · Tabuteau · 2024 [cited by applicant]
US 20240041863A1 · Tabuteau · 2024 [cited by applicant]
US 20240050383A1 · Tabuteau · 2024 [cited by applicant]
US 20240066025A1 · Tabuteau · 2024 [cited by applicant]
US 20240115524A1 · Tabuteau · 2024 [cited by applicant]
US 20240148719A1 · Tabuteau · 2024 [cited by examiner]
US 20240156751A1 · Tabuteau · 2024 [cited by applicant]
US 20240165104A1 · Tabuteau · 2024 [cited by applicant]
US 20240189302A1 · Tabuteau · 2024 [cited by applicant]
US 20240197656A1 · Tabuteau · 2024 [cited by applicant]
US 20240197720A1 · Tabuteau · 2024 [cited by examiner]
US 20240238276A1 · Tabuteau · 2024 [cited by applicant]
US 20240252451A1 · Tabuteau · 2024 [cited by applicant]
US 20240269130A1 · Tabuteau · 2024 [cited by applicant]
US 20240299319A1 · Tabuteau · 2024 [cited by applicant]
US 20240299320A1 · Tabuteau · 2024 [cited by applicant]
BR 102016010170A2 · 2017 [cited by applicant]
EP 4183391A1 · 2023 [cited by applicant]
KR 101612197B1 · 2016 [cited by applicant]
WO 1998050044 · 1998 [cited by applicant]
WO 2003086362A2 · 2003 [cited by applicant]
WO 2004089873A1 · 2004 [cited by applicant]
WO 2009006194 · 2009 [cited by applicant]
WO 2009050726A2 · 2009 [cited by applicant]
WO WO2015034846A1 · 2015 [cited by examiner]
WO 2015069809A1 · 2015 [cited by applicant]
WO 2016125108A1 · 2016 [cited by applicant]
WO 2020146412A1 · 2020 [cited by applicant]
WO 2021202329A1 · 2021 [cited by applicant]
WO 2021202419A1 · 2021 [cited by applicant]
WO 2022119981A1 · 2022 [cited by applicant]
WO 2023004064A1 · 2023 [cited by applicant]
McKeon et al., The alcohol withdrawal syndrome, J Neurol Neurosurg Psychiatry, 2008, 79, 854-862 (Year: 2008). [cited by examiner]
Spravato (esketamine), Highlights of Prescribing Information, revised Jul. 2020. [cited by applicant]
Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), Highlights of Prescribing Information, revised Dec. 2022. [cited by applicant]
Aplenzin (bupropion hydrobromide), Highlights of Prescribing Information, revised Mar. 2022. [cited by applicant]
Tod et al., Quantitative Prediction of Cytochrome P450 (CYP) 2D6-Mediated Drug Interactions, Clinical Pharmacokinetics, 50(8), 519-530, Aug. 2011. [cited by applicant]
Kotlyar et al., Inhibition of CYP2D6 Activity by Bupropion, Journal of Clinical Psychopharmacology, 25(2), 226-229, Jun. 2005. [cited by applicant]
Pope et al., Pharmacokinetics of Dextromethorphan after Single or Multiple Dosing in Combination with Quinidine in Extensive and Poor Metabolizers, The Journal of Clinical Pharmacology, 44(10), 1132-1142, Oct. 2004. [cited by applicant]
Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride), Highlights of Prescribing Information and Medication Guide, issued Dec. 2022. [cited by applicant]
International Preliminary Report on Patentability, PCT/US2021/061492, mailed on Jun. 15, 2023. [cited by applicant]
International Search Report and Written Opinion, PCT/US2021/061492 received on Jun. 15, 2023. [cited by applicant]
International Search Report and Written Opinion, PCT/US2022/012768 received on Jul. 5, 2023. [cited by applicant]
International Search Report and Written Opinion, PCT/US2023/067062 mailed on Jul. 12, 2023. [cited by applicant]
Axsome Therapeutics Announces Topline Results of the Stride-1 Phase 3 Trial in Treatment Resistant Depression and Expert Call to Discuss Clinical Implications, Mar. 2020 (retrieved from internet on Jul. 19, 2023). <axso… [cited by applicant]
Anderson, A.; et al. “Efficacy and Safety of AXS-05, an Oral NMDA Receptor Antagonist with Multimodal Activity, in Major Depressive Disorder: Results of a Phase 2, Double-Blind, Active-Controlled Trial” ASCP Annual Meet… [cited by applicant]
O'gorman, C; et al. “Rapid Effects of AXS 05, an Oral NMDA Receptor Antagonist, in Major Depressive Disorder: Results from Two Randomized, Double Blind, Controlled Trials” ASCP Annual Meeting 2021 (retrieved from intern… [cited by applicant]
O'gorman, C.; et al. “PMH40 Effects of AXS-05 on Patient Reported Depressive Symptoms in Major Depressive Disorder: Results from the GEMINI Trial” <doi.org/10.1016/j.jval.2021.04.662> (retrieved from internet on Jul. 19… [cited by applicant]
O'gorman, C.; et al. “P246. Rapid Antidepressant Effects and MADRS Core Symptom Improvements With AXS-05, an Oral NMDA Receptor Antagonist, in Major Depressive Disorder: Results From Two Randomized, Double-Blind, Contro… [cited by applicant]
International Preliminary Report on Patentability, PCT/US2022/012768, mailed on Jul. 27, 2023. [cited by applicant]
Nofziger et al., Evaluation of dextromethorphan with select antidepressant therapy for the treatment of depression in the acute care psychiatric setting, Mental Health Clinician, 9(2), 76-81, Mar. 2019. [cited by applicant]
Update: Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies, FDA, retrieved Mar. 2021. [cited by applicant]
FDA Draft Guidance on Bupropion Hydrochloride, revised Mar. 2013. [cited by applicant]
Forfivo XL (bupropion hydrochloride) extended-release tablets, for oral use, Highlights of Prescribing Information, revised Dec. 2019. [cited by applicant]
Forfivo XL (Bupropion HCI) extended-release tablet, NDA 22497, Jan. 25, 2010. [cited by applicant]
Wellbutrin XL (bupropion hydrochloride extended-release), Highlights of Prescribing Information, revised Mar. 2022. [cited by applicant]
Baker T. E. et al., Human Milk and Plasma Pharmacokinetics of Single-Dose Rimegepant 75mg in Healthy Lactating Women, Breastfeeding Medicine, 17(3), 277-282, 2022. [cited by applicant]
Berle J. O. et al., Antidepressant Use During Breastfeeding, Current Women's Health Reviews, 7(1), 28-34, Feb. 2011. [cited by applicant]
Briggs G. G. et al., Excretion of bupropion in breast milk, Annals of Pharmacotherapy, 27(4):431-433, Apr. 1993. [cited by applicant]
Chad L. et al., Update on antidepressant use during breastfeeding, Canadian Family Physician, 59(6), 633-634, Jun. 2013. [cited by applicant]
Chaudron L. H. et al., Bupropion and Breastfeeding: A case of a possible Infant Seizure, The Journal of clinical psychiatry, 65(6), 881-882, Jun. 2004. [cited by applicant]
Davis M. F. et al., Bupropion Levels in Breast Milk for 4 Mother-Infant Pairs: More Answers to Lingering Questions, J. Clin. Psychiatry, 70(2), 297-298, Feb. 2009. [cited by applicant]
Di Scalea T. L. et al., Antidepressant Medication Use during Breastfeeding, Clinical obstetrics and gynecology, 52 (3): 483-497, Sep. 2009. [cited by applicant]
Dwoskin L. P. et al., Review of the Pharmacology and Clinical Profile of Bupropion, and Antidepressant and Tobacco Use Cessation Agent, CNS Drug Reviews, 12(3-4), 178-207, Sep. 2006. [cited by applicant]
Gentile S, The safety of newer antidepressants in pregnancy and breastfeeding, Drug Safety, 28(2), 137-152, Feb. 2005. [doi: 10.2165/00002018-200528020-00005. PMID: 15691224.] [cited by applicant]
Haas J. S. et al., Bupropion in breast milk: an exposure assessment for potential treatment to prevent post-partum tobacco use, Tobacco Control, 13(1), 52-56, Mar. 2004. [cited by applicant]
Ram D. et al., Antidepressants, anxiolytics, and hypnotics in pregnancy and lactation, Indian J Psychiatry, 57(Suppl 2): S354-S371, Jul. 2015. [doi: 10.4103/0019-5545.161504]. [cited by applicant]
Weissman A. M. et al., Pooled Analysis of Antidepressant Levels in Lactating Mothers, Breast Milk, and Nursing Infants, Am J Psychiatry, 161(6), 1066-1078, Jun. 2004. [cited by applicant]
Horn J. R. et al., Get to Know an Enzyme: CYP2D6, Pharmacy Times, Jul. 2008, retrieved on Aug. 28, 2023. [cited by applicant]
International Search Report and Written Opinion, PCT/US2023/069286 mailed on Aug. 22, 2023. [cited by applicant]
International Search Report and Written Opinion, PCT/US2023/069239 mailed on Aug. 28, 2023. [cited by applicant]
International Search Report and Written Opinion, PCT/US2023/069367 mailed on Aug. 28, 2023. [cited by applicant]
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