Claims for Patent: 11,980,617

Summary for Patent: 11,980,617

Title:	Methods of treating acute depression and/or acute anxiety
Abstract:	The disclosure provides methods for the acute treatment of depression and/or anxiety, for the enhancement of mTOR (e.g., mTORC1) signaling, and for the reduction of neuroinflammation, comprising administering to a patient in need thereof, a therapeutically effective amount of a 5-HT2A or 5-HT2A/D2 receptor ligand, e.g. lumateperone.
Inventor(s):	Gretchen Snyder, Robert Davis, Lawrence P. Wennogle
Assignee:	Intra Cellular Therapies Inc
Application Number:	US16/981,639
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,980,617
Patent Claims:	1. A method of treating acute depression and/or acute anxiety, comprising administering to a patient in need thereof, a therapeutically effective amount of a Compound of Formula I: in free, or pharmaceutically acceptable salt form. 2. The method according to claim 1, wherein the Compound of Formula I is in the form of the tosylate salt. 3. The method according to claim 1, wherein the method comprises once daily administration of a unit dosage for subcutaneous or transmucosal administration comprising the compound of Formula I in tosylate salt form in an amount equivalent to 0.5 to 30 mg of free base and a pharmaceutically acceptable diluent or carrier. 4. The method according to claim 1, wherein the condition to be treated is acute anxiety. 5. The method according to claim 1, wherein the condition to be treated is acute depression. 6. The method according to claim 5, wherein the acute depression is treatment resistant depression. 7. The method according to claim 1, wherein the compound of Formula I is in combination with an effective amount of an additional anxiolytic or antidepressant agent. 8. The method according to claim 7, wherein the additional anxiolytic or antidepressant agent is selected from one or more compounds in free or pharmaceutically acceptable salt form, selected from selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and atypical antipsychotics. 9. The method according to claim 1, wherein the therapeutically effective amount of the Compound of Formula I is sufficient to enhance mTOR signaling. 10. The method according to claim 1, wherein the therapeutically effective amount of the Compound of Formula I is sufficient to reduce neuroinflammation. 11. The method according to claim 1, wherein the compound of Formula I is administered intra-nasally, subcutaneously, intravenously, orally, or sub-lingually, or intra-peritoneally or buccally. 12. The method according to claim 1, wherein the method further comprises the concurrent administration of an NMDA receptor antagonist. 13. The method according to claim 1, wherein the method further comprises the concurrent administration of a NMDA receptor allosteric modulator. 14. The method according to claim 1, wherein the method provides the patient with an acute response to treatment with the therapeutic agent or agents. 15. The method according to claim 1, wherein the patient has not responded to, or has not responded adequately to, or who suffers undesirable side effects from, treatment with another antidepressant agent. 16. The method according to claim 1, wherein the Compound of Formula I is administered as monotherapy. 17. The method according to claim 1, wherein the therapeutically effective amount of the Compound of Formula I does not put the patient at risk for sedation, dissociation, abuse, misuse, or suicidal ideation, or does not result in hypertension within four hours after administration of a dose of the Compound of Formula I. 18. The method according to claim 4, wherein the acute anxiety is selected from a short-duration anxious episode associated with generalized anxiety disorder, panic disorder, specific phobias, or social anxiety disorder, or social avoidance. 19. The method according to claim 5, wherein the acute depression is selected from an acute major depressive episode, an acute short-duration depressive episode, and an acute recurrent brief depressive episode. 20. The method according to claim 6, wherein the treatment resistant depression is depression which has not responded to treatment with an antidepressant agent selected from a selective serotonin reuptake inhibitor, a serotonin reuptake inhibitor, a tricyclic antidepressant, a monoamine oxidase inhibitor, a norepinephrine reuptake inhibitor, a dopamine reuptake inhibitor, an serotonin/norepinephrine reuptake inhibitor, a serotonin/dopamine reuptake inhibitor, a norepinephrine/dopamine reuptake inhibitor, triple reuptake inhibitor, a serotonin receptor antagonist, or any combination thereof. 21. The method according to claim 1, wherein the anxiety or depression is alleviated within one week of treatment. 22. The method according to claim 1, wherein the patient shows an acute response to treatment within less than 2 weeks of treatment. 23. The method according to claim 4, wherein the anxiety or depression is alleviated within one week of treatment. 24. The method according to claim 4, wherein the patient shows an acute response to treatment within less than 2 weeks of treatment. 25. The method according to claim 5, wherein the anxiety or depression is alleviated within one week of treatment. 26. The method according to claim 5, wherein the patient shows an acute response to treatment within less than 2 weeks of treatment. 27. The method according to claim 19, wherein the anxiety or depression is alleviated within one week of treatment. 28. The method according to claim 19, wherein the patient shows an acute response to treatment within less than 2 weeks of treatment. 29. The method according to claim 1, wherein the method comprises once daily administration of a unit dosage for oral administration in the form of a tablet or capsule comprising the compound of Formula I in tosylate salt form in an amount equivalent to 1 to 60 mg of free base, and a pharmaceutically acceptable diluent or carrier. 30. The method according to claim 5, wherein the method comprises once daily administration of a unit dosage for oral administration in the form of a tablet or capsule comprising the compound of Formula I in tosylate salt form in an amount equivalent to 1 to 60 mg of free base, and a pharmaceutically acceptable diluent or carrier. 31. The method according to claim 19, wherein the method comprises once daily administration of a unit dosage for oral administration in the form of a tablet or capsule comprising the compound of Formula I in tosylate salt form in an amount equivalent to 1 to 60 mg of free base, and a pharmaceutically acceptable diluent or carrier. 32. The method according to claim 5, wherein the acute depression is bipolar depression. 33. The method according to claim 5, wherein the acute depression is major depressive disorder. 34. The method according to claim 19, wherein the acute major depressive episode is associated with bipolar disorder. 35. The method according to claim 19, wherein the acute major depressive episode is associated with major depressive disorder.