IP Library › Granted Patent US 12,268,686
Granted Patent B2
US 12,268,686 · App. 18/319,425 · Granted Apr 8, 2025

Transmucosal methods for treating psychiatric and neurological conditions

Inventors: Peng Li (New Milford, NJ); Wei Yao (New Milford, NJ); Robert Davis (San Diego, CA)
Assignee: INTRA-CELLULAR THERAPIES, INC.
A61K31/4985A61K9/0036A61K9/0043A61K9/006A61K9/06
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Quick Facts
Patent No.
US 12,268,686
App. No.
18/319,425
Granted
Apr 8, 2025
Kind
B2
Abstract

The disclosure provides new transmucosal and subcutaneous pharmaceutical compositions comprising 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one or 1-(4-fluoro-phenyl)-4-((6bR,10aS)-2,2-d 2 -3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one or comprising -(4-fluoro-phenyl)-4-((6bR,10aS)-1,1,2,2-d 4 -3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one, in free base, co-crystal or salt form, together with methods of making and using them.

Claims (33)

1. A transmucosal pharmaceutical formulation comprising 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one (Compound of Formula I) in tosylate salt form; wherein the formulation is a rapidly dissolving tablet or wafer, or a sublingual tablet or wafer, and wherein the formulation comprises from 0.01 to 30 mg of the Compound of Formula I (free base equivalent).

2. The formulation of claim 1 , wherein the formulation comprises from 0.01 to 10 mg of the Compound of Formula I (free base equivalent).

3. The formulation of claim 1 , wherein the formulation comprises from 10 to 30 mg of the Compound of Formula I (free base equivalent).

4. The formulation of claim 1 , wherein the formulation is absorbed by the mucosa or dissolves in less than 30 seconds after administration.

5. The formulation of claim 1 , wherein the formulation further comprises one or more excipients selected from the group consisting of plasticizers, surfactants, drying agents, flavors, sweeteners, binders, disintegrants, humectants, wetting agents, antioxidants, buffering agents, and thickening agents.

6. The formulation of claim 5 , wherein the one or more excipients comprise one or more gums, polysaccharides, polysaccharide derivatives, gelatins, synthetic polymers, sugars, sugar alcohols, or any combination thereof.

7. The formulation of claim 1 , wherein the formulation further comprises one or more excipients selected from carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, bovine gelatin, porcine gelatin, avian gelatin, fish gelatin, dextrose, lactose, galactose, glucose, ribose, sucrose, trehalose, mannitol, maltitol, lactitol, sorbitol, xylitol, erythritol, galactitol, and inositol, or any combination thereof.

8. The formulation of claim 7 , wherein the formulation further comprises one or more excipients selected from bovine gelatin, porcine gelatin, avian gelatin, fish gelatin, mannitol, maltitol, lactitol, sorbitol, xylitol, erythritol, galactitol, and inositol, or any combination thereof.

9. The formulation of claim 8 , wherein the formulation further comprises one or more fish gelatins and mannitol.

10. The formulation of claim 8 , wherein the one or more fish gelatins comprise a mixture of high molecular weight and low molecular weight fish gelatins.

11. The formulation of claim 10 , wherein the formulation comprises from 0.01 to 10 mg of the Compound of Formula I (free base equivalent).

12. The formulation of claim 10 , wherein the formulation comprises from 10 to 30 mg of the Compound of Formula I (free base equivalent).

13. The formulation of claim 1 , wherein the formulation comprises from 5 to 20 mg of the Compound of Formula I (free base equivalent).

14. The formulation of claim 1 , wherein the formulation comprises from 0.05 to 8 mg of the Compound of Formula I (free base equivalent).

15. The formulation of claim 10 , wherein the formulation comprises from 5 to 20 mg of the Compound of Formula I (free base equivalent).

16. The formulation of claim 10 , wherein the formulation comprises from 0.05 to 8 mg of the Compound of Formula I (free base equivalent).

17. A method for the prophylaxis or treatment of a disease or abnormal condition involving or mediated by the 5-HT 2A receptor, serotonin transporter (SERT), and/or dopamine D 1 /D 2 receptor signaling pathways, in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of the formulation of claim 1 , wherein the disease or abnormal condition is selected from the group consisting of obesity, anorexia, bulimia, depression, major depressive disorder (MDD), anxiety, psychosis, schizophrenia, obsessive-compulsive disorder, sexual disorders, migraine, attention deficit disorder, attention deficit hyperactivity disorder, sleep disorders, conditions associated with cephalic pain, social phobias, dementia, Alzheimer's Disease, Parkinson's dementia, and bipolar disorder.

18. The method of claim 17 , wherein the disease or abnormal condition is selected from the group consisting of depression, major depressive disorder (MDD), anxiety, psychosis, schizophrenia, and bipolar disorder.

19. The method of claim 17 , wherein the disease or abnormal condition is selected from the group consisting of obsessive-compulsive disorder, attention deficit disorder, and attention deficit hyperactivity disorder.

20. The method of claim 17 , wherein the formulation further comprises one or more excipients selected from carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, bovine gelatin, porcine gelatin, avian gelatin, fish gelatin, dextrose, lactose, galactose, glucose, ribose, sucrose, trehalose, mannitol, maltitol, lactitol, sorbitol, xylitol, erythritol, galactitol, and inositol, or any combination thereof.

21. The method of claim 20 , wherein the formulation further comprises one or more excipients selected from bovine gelatin, porcine gelatin, avian gelatin, fish gelatin, mannitol, maltitol, lactitol, sorbitol, xylitol, erythritol, galactitol, and inositol, or any combination thereof.

22. The method of claim 21 , wherein the formulation further comprises one or more fish gelatins and mannitol.

23. The method of claim 22 , wherein the one or more fish gelatins comprise a mixture of high molecular weight and low molecular weight fish gelatins.

24. The method of claim 23 , wherein the formulation comprises from 0.01 to 10 mg of the Compound of Formula I (free base equivalent).

25. The method of claim 23 , wherein the formulation comprises from 10 to 30 mg of the Compound of Formula I (free base equivalent).

26. The method of claim 23 , wherein the formulation comprises from 5 to 20 mg of the Compound of Formula I (free base equivalent).

27. A transmucosal pharmaceutical formulation comprising 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one (Compound of Formula I) in tosylate salt form; wherein the formulation is a rapidly dissolving tablet or wafer, or a sublingual tablet or wafer, and wherein the formulation comprises from 0.01 to 30 mg of the Compound of Formula I (free base equivalent); and wherein the formulation further comprises one or more fish gelatins.

28. The formulation according to claim 27 , wherein the formulation further comprises one or more excipients selected from bovine gelatin, porcine gelatin, avian gelatin, mannitol, maltitol, lactitol, sorbitol, xylitol, erythritol, galactitol, and inositol, or any combination thereof.

29. The formulation according to claim 28 , wherein the formulation further comprises mannitol.

30. The formulation according to claim 29 , wherein the one or more fish gelatins comprise a mixture of high molecular weight and low molecular weight fish gelatins.

31. The formulation of claim 30 , wherein the formulation is absorbed by the mucosa or dissolves in less than 30 seconds after administration.

32. A method for the treatment of a disease or abnormal condition involving or mediated by the 5-HT 2A receptor, serotonin transporter (SERT), and/or dopamine D 1 /D 2 receptor signaling pathways, in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of the formulation of claim 27 , wherein the disease or abnormal condition is selected from the group consisting of depression, major depressive disorder (MDD), anxiety, psychosis, schizophrenia, dementia, Alzheimer's Disease, and bipolar disorder.

33. The method according to claim 32 , wherein the Compound of Formula I is administered sublingually.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2023
From: DAVIS, ROBERT; YAO, WEI; LI, PENG
To: INTRA-CELLULAR THERAPIES, INC.
Reel/Frame 064298/0699 →
Continuity (5)
Continuation 17338573 · Jun 3, 2021
Continuation 16900746 · Jun 12, 2020
Continuation 15934860 · Mar 23, 2018
Provisional Application 62476538 · Mar 24, 2017
Related Publication 20230301995A1 · Sep 28, 2023
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Davis, et al., “ITI-007 in the Treatment of Schizophrenia: From Novel Pharmacology to Clinical Outcomes,” [cited by applicant]
Davis et al., “ITI-007: A Novel Treatment for Behavioral Disturbances Associated with Dementia and Related Disorders,” Clinical Trials in Alzheimer's Disease (CTAD) Congress 2014 (2014) (poster presentation). [cited by applicant]
Davis et al., “Rationale for the Development of Low Doses of ITI-007 for the Treatment of Behavioral Disturbances Associated with Dementia,” The Journal of Prevention of Alzheimer's Disease, 2(4):302 (2015) (Clinical Tr… [cited by applicant]
Davis, et al., “Lumateperone (ITI-007), A Novel Drug in Development for the Treatment of Agitation in Patients with Dementia, including Alzheimer's Disease: Rationale and Clinical Design,” The Journal of Prevention of A… [cited by applicant]
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Foster et al., “Emerging Approaches for Treatment of Schizophrenia: Modulation of Cholinergic Signaling,” Discov. Med., vol. 14, No. 79, p. 413-420 (2012). [cited by applicant]
Friedman, M.J.., “Current and Future Drug Treatment for Posttraumatic Stress Disorder Patients”, [cited by applicant]
Gouyette, A., “Synthesis of Deuterium-labelled Elliptinium and its Use in Metabolic Studies,” [cited by applicant]
Gramigna, “Lumateperone Safe, Effective for Depressive Symptoms Among Patients with Bipolar Disorders,” American Society of Clinical Psychopharmacology Annual Meeting, Jun. 2, 2020, 3 pages. [cited by applicant]
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Haskins, N.J., “The Application of Stable Isotopes in Biomedical Research,” [cited by applicant]
Helfer et al., “Efficacy and Safety of Antidepressants Added to Antipsychotics for Schizophrenia: A Systematic Review and Meta-Analysis,” Am. J. Psychiatry, vol. 173, No. 9, p. 876-886 (2016). [cited by applicant]
Hlavinka, “Schizophrenia Tx Eases Depression in Bipolar Disorder: Lumateperone Offers Greater Rate of Response, Remission versus Placebo,” Medpage Today, 7 pages, (2020); https://www.medpagetoday.com/meetingcoverage/psy… [cited by applicant]
Honma, S., et al., “The Metabolism of Roxatidine Acetate Hydrochloride: Liberation of Deuterium from the Piperidine Ring during Hydroxylation,” [cited by applicant]
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Howland, R.H., “Deuterated Drugs,” Journal of Psychosocial Nursing and Mental Health Services, 53(9): 13-16 (2015). [cited by applicant]
Izrayelit, L., “Schizoaffective Disorder and PTSD Successfully Treated With Olanzapine and Supportive Psychotherapy”, [cited by applicant]
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Khorana, et al., “Gamma-Carbolines: Binding at 5-HT5A Serotonin Receptors,” Bioorganic & Medicinal Chemistry, vol. 11, pp. 717-722, p. 718 Table 1, (2003). [cited by applicant]
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Kumar et al., “Lumateperone: A New Treatment Approach for Neuropsychiatric Disorders,” Drugs of Today, vol. 54, No. 12, p. 713-719, (2018). [cited by applicant]
Lammers et al., “Risperidone Long-acting Injection in Schizophrenia Spectrum Illnesses Compared to First Generation Depot Antipsychotics in an Outpatient Setting in Canada,” [cited by applicant]
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Li, et al., “Discovery of a Tetracyclic Quinoxaline Derivative as a Potent and Orally Active Multifunctional Drug Candidate for the Treatment of Neuropsychiatric and Neurological Disorders,” [cited by applicant]
Lieberman, et al., “ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial,” [cited by applicant]
Lin, et al., “Dosage and Duration of Antipsychotic Treatment in Demented Outpatients with Agitation or Psychosis,” [cited by applicant]
Lipschitz, et al., “Childhood Posttraumatic Stress Disorder: A Review of Neurobiologic Sequelae,” [cited by applicant]
Liriano et al., “Ketamine as treatment for post-traumatic stress disorder: a review.” Drugs in Context, vol. 8, 7 pages (2019). [cited by applicant]
Madhusoodanan, et al., “Pharmacological Management of Behavioral Symptoms Associated with Dementia,” [cited by applicant]
Makadia et al., “Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier,” [cited by applicant]
Marek et al. Synergistic Action of 5-HT2A Antagonists and Selective Serotonin Reuptake Inhibitors in Neuropsychiatric Disorders. Neuropsychopharmacology, 2003. vol. 28, pp. 402-412. (Year: 2003). [cited by applicant]
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Medisorb Fact Sheet in Medisorb Microspheres Technology (Jan. 2009) at https://static.secure.website/wscfus/6472891/uploads/Medisorb.pdf (retrieved from the internet May 18, 2020) (Year: 2009). [cited by applicant]
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O'Gorman, et al., “Lumateperone (ITI-007): A Novel Investigational Agent with Broad Therapeutic Potential Across Multiple Neuropsychiatric Disorders,” Poster p. 1.g.038, European College of Neuropsychopharmacology (ECNP… [cited by applicant]
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Palanisamy, M. et al., “Cellulose-Based Matrix Microspheres of Prednisolone Inclusion Complex; Preparation and Characterization.” American Association of Pharmaceutical Scientists PharmSciTech, vol. 12, No. 1, pp. 388-4… [cited by applicant]
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Pieniaszek, et al., “Moricizine Bioavailability via Simultaneous Dual, Stable Isotope Administration: Bioequivalence Implications,” [cited by applicant]
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