IP Library Granted Patent US 11,576,911
Granted Patent B2
US 11,576,911 · App. 16/812,382 · Granted Feb 14, 2023

Composition and method for treatment of depression and psychosis in humans

Inventor: Daniel C. Javitt (Ft. Lee, NJ)
Assignee: GLYTECH LLC
A61K31/496A61K31/06A61K31/135A61K31/138A61K31/381A61K31/42A61K31/431A61K31/4525A61K31/519A61K31/55A61K31/551A61K31/553A61K31/554A61K45/06A61K2300/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,576,911
App. No.
16/812,382
Granted
Feb 14, 2023
Kind
B2
Abstract

This application relates to combination compositions for use in treatment of depression, and which can alleviate the anxiogenic side effects of certain antidepressant and antipsychotic medications. Methods for treatment of depression and medicament side effects, particular anxiety, akathisia, and associated suicidality are also described herein.

Claims (15)

1. A method for treating a subject with depression or suicidality and in need of treatment with an atypical antipsychotic, but in need of reduced side effects thereof, the method comprising:

administering to the subject an atypical antipsychotic that is a combined dopamine D2/5-HT2A receptor antagonist in a composition comprising

an NMDAR-antagonist effective amount of D-cycloserine; and

an effective amount of an atypical antipsychotic that is a combined dopamine D2/5-HT2A receptor antagonist,

wherein the NMDAR-antagonist effective amount of D-cycloserine is sufficient to produce a sustained blood plasma concentration in excess of 25 microgram/mL but lower than 125 microgram/mL, and

wherein the atypical antipsychotic is lurasidone, and wherein the effective amount of the lurasidone is between 20 mg-200 mg per day,

thereby treating the subject with the atypical antipsychotic, but with reduced side effects.

2. The method of claim 1 , wherein the NMDAR-antagonist effective amount of D-cycloserine is in excess of 500 mg/day and less than 1000 mg.

3. The method of claim 1 , wherein the NMDAR antagonist effective amount of D-cycloserine is in excess of 10 mg/kg/day, and is less than 25 mg/kg/d.

4. The method of claim 1 , wherein the pharmaceutical composition is formulated for sustained release.

5. The method of claim 1 , wherein the composition further comprises an enteric coating.

6. The method of claim 1 , wherein the NMDAR-antagonist effective amount of D-cycloserine is provided as a prodrug.

7. The method of claim 1 , wherein the side effects are at least one anxiogenic side effect.

8. The method of claim 1 , wherein the at least one anxiogenic side effect is selected from the group consisting of akathisia, agitation, anxiety, and suicidality.

9. The method of claim 1 , wherein the depression is major depression or bipolar depression.

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 Jan 5, 2021
From: JAVIT, DANIEL C
To: GLYTECH LLC
Reel/Frame 054806/0788 →
Continuity (7)
Division 15987932 · May 24, 2018
Continuation In Part 15650912 · Jul 16, 2017
Continuation 13936198 · Jul 7, 2013
Provisional Application 62518020 · Jun 12, 2017
Provisional Application 61741114 · Jul 12, 2012
Provisional Application 61741115 · Jul 12, 2012
Related Publication 20200206219A1 · Jul 2, 2020