Claims for Patent: 12,090,155

Summary for Patent: 12,090,155

Title:	Methods
Abstract:	The disclosure provides methods for the treatment of Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone, in free or pharmaceutically acceptable salt form, optionally in deuterated form.
Inventor(s):	Sharon Mates, Robert Davis, Kimberly Vanover
Assignee:	Intra Cellular Therapies Inc
Application Number:	US18/494,754
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,090,155
Patent Claims:	1. A method for the treatment of a major depressive episode associated with Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone in mono-tosylate salt form, wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone mono-tosylate in combination or association with a pharmaceutically acceptable diluent or carrier. 2. The method of claim 1, wherein the salt is a solid crystalline salt. 3. The method of claim 1, wherein the patient also suffers from mixed affective episodes. 4. The method of claim 1, wherein the patient also suffers from hypomanic episodes. 5. The method of claim 1, wherein the method suppresses mania or hypomania. 6. The method of claim 1, wherein the method does not trigger manic or hypomanic episodes or rapid cycling. 7. The method of claim 1, wherein during the course of treatment the patient shows improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score and/or shows improvement in the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S). 8. The method of claim 1, wherein the method does not result in one or more of hyperglycemia, dyslipidemia, weight gain, suicidal ideation, suicidal thoughts, or extrapyramidal symptoms. 9. The method of claim 1, wherein the patient is concurrently receiving a mood-stabilizing agent. 10. The method of claim 1, wherein the patient was previously treated with a selective serotonin reuptake inhibitor. 11. The method of claim 1, wherein the patient was previously treated with an atypical antipsychotic. 12. The method of claim 1, wherein the patient was previously treated with an antipsychotic selected from haloperidol, aripiprazole, quetiapine, olanzapine, risperidone, lurasidone, paliperidone, iloperidone, ziprasidone, brexpiprazole, asenapine, clozapine, and zotepine. 13. The method of claim 1, wherein during the course of treatment, the patient does not exhibit emergence of mania or hypomania as measured by the Young Mania Rating Scale (YMRS). 14. The method of claim 9, wherein the mood-stabilizing agent is selected from lithium, carbamazepine, oxcarbazepine, lamotrigine, and valproate. 15. The method of claim 9, wherein the mood-stabilizing agent is lithium or valproate. 16. The method of claim 15, wherein the valproate is valproate semisodium, sodium valproate, or another free, salt or complexed form of valproic acid. 17. The method of claim 7, wherein the patient shows the improvement in the MADRS total score and/or the improvement in CGI-BP-S within 8 days or less after initiation of treatment. 18. The method of claim 1, wherein the lumateperone mono-tosylate is administered as monotherapy. 19. The method of claim 1, wherein during the course of treatment the patient shows improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 20. The method of claim 1, wherein during the course of treatment the patient shows improvement in the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S). 21. The method of claim 8, wherein the method does not result in one or more of hyperglycemia, dyslipidemia, weight gain, or extrapyramidal symptoms. 22. A method for the treatment of a depressive episode associated with Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone in mono-tosylate salt form, wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone mono-tosylate in combination or association with a pharmaceutically acceptable diluent or carrier. 23. The method of claim 22, wherein during the course of treatment the patient shows improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 24. The method of claim 22, wherein during the course of treatment the patient shows improvement in the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S). 25. The method of claim 22, wherein the treatment does not result in one or more of hyperglycemia, dyslipidemia, weight gain, or extrapyramidal symptoms. 26. The method of claim 22, wherein the lumateperone mono-tosylate is administered as monotherapy. 27. The method of claim 22, wherein the patient is concurrently receiving a mood-stabilizing agent selected from lithium and valproate.