IP Library Granted Patent US 10,660,887
Granted Patent B2
US 10,660,887 · App. 15/650,912 · Granted May 26, 2020

Composition and method for treatment of depression and psychosis in humans

Inventor: Daniel C. Javitt (Ft. Lee, NJ)
Assignee: GLYTECH, LLC
A61K31/496A61K31/06A61K31/135A61K31/138A61K31/381A61K31/42A61K31/431A61K31/4525A61K31/519A61K31/55A61K31/551A61K31/553A61K31/554A61K45/06
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Quick Facts
Patent No.
US 10,660,887
App. No.
15/650,912
Granted
May 26, 2020
Kind
B2
Abstract

Compositions and methods for the treatment of depression and psychoses in humans are disclosed. More particularly, the invention is directed to formulations containing antipsychotic and/or antidepressant medications and also containing an NMDAR antagonist. The present Invention Is also directed to methods tor the treatment of humans suffering from depression and other psychoses, including, schizophrenia, by administration of the inventive compositions in antidepressant and/or antipsychotic effective amounts.

Claims (23)

1. A method for reducing at least one anxiogenic side effect of a selective 5-HT2A antagonist, the method comprising:

administering to the subject an anxiogenic side effect-inducing amount of

a selective 5-HT2A antagonist selected from the group consisting of volinanserin (MDL-100907), eplivanserin (SR-46,349), pimavanserin, and pruvanserin (EMD-281,014);

once akathisia is induced, continuing to administer the selective 5-HT2A antagonist at a same dosage and frequency that caused the anxiogenic side effect; and

administering a therapeutically effective amount of a second composition comprising D-cycloserine (DCS) at a dosage in excess of 500 mg/day, wherein the DCS produces a NMDA receptor antagonistic blood plasma concentration measured at greater than 25 micrograms/mL, thereby reducing the anxiogenic side effect.

2. The method of claim 1 , wherein the subject has a neuropsychiatric disorder.

3. The method of claim 2 , wherein the neuropsychiatric disorder is a depressive disorder.

4. The method of claim 3 , wherein the depressive disorder is bipolar disorder.

5. The method of claim 3 , wherein the depressive disorder is major depressive disorder.

6. The method of claim 1 , wherein the selective 5-HT2A antagonist and the second composition are administered intramuscularly, intravenously, intraperitoneally, parentally, or orally.

7. The method of claim 1 , wherein the selective 5-HT2A antagonist and the second composition are formulated as a single composition for administration to the subject.

8. The method of claim 1 , wherein the anxiogenic side effect s akathisia.

9. A method for administering a selective 5-HT2A receptor antagonist to a subject, but with reduced anxiogenic side effects, the method comprising:

administering to a subject in need thereof

an effective, side-effect-inducing amount of a selective 5-HT2A receptor antagonist selected from the group consisting of volinanserin (MDL-100907), eplivanserin (SR-46,349), pimavanserin, and pruvanserin (EMD-281,014); and

a therapeutically effective amount of D-cycloserine (DCS) at a dosage in excess of 500 mg/day, wherein the administration of DCS produces a NMDA receptor antagonistic blood plasma concentration measured at greater than 25 micrograms/mL.

10. The method claim 9 , wherein the subject has a neuropsychiatric disorder.

11. The method of claim 10 , wherein the neuropsychiatric disorder is a depressive disorder.

12. The method of claim 11 , wherein the depressive disorder is bipolar disorder.

13. The method of claim 11 , wherein the depressive disorder is major depressive disorder.

14. The method of claim 9 , wherein the selective 5-HT2A antagonist and the DCS are administered intramuscularly, intravenously, intraperitoneally, parentally, or orally.

15. The method of claim 9 , wherein the wherein the 5-HT2A antagonist and the DCS are formulated as a single composition for administration to the subject.

16. The method of claim 9 , wherein the anxiogenic side effect is akathisia.

Assignments (2)
SECURITY INTEREST Recorded Sep 20, 2024
From: NRX PHARMACEUTICALS, INC.; HOPE THERAPEUTICS, INC.; NEURORX, INC.
To: ANSON INVESTMENTS MASTER FUND LP; ANSON EAST MASTER FUND LP
Reel/Frame 068647/0346 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2017
From: JAVITT, DANIEL C.
To: GLYTECH, LLC
Reel/Frame 043857/0360 →
Continuity (4)
Continuation 13936198 · Jul 7, 2013
Provisional Application 61741114 · Jul 12, 2012
Provisional Application 61741115 · Jul 12, 2012
Related Publication 20170312275A1 · Nov 2, 2017