IP Library Granted Patent US 8,278,276
Granted Patent B2
US 8,278,276 · App. 13/362,985 · Granted Oct 2, 2012

Methods of treating autism

Assignee: Seaside Therapeutics, Inc.
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Quick Facts
Patent No.
US 8,278,276
App. No.
13/362,985
Granted
Oct 2, 2012
Kind
B2
Abstract

Subjects having autism are treated with a composition that includes gamma-aminobutyric acid agonists. The gamma-aminobutyric acid agonist (GABA) can be a GABA(B) agonist, such as baclofen.

Claims (26)

1. A method of improving a social domain in a human having autism spectrum disorder, comprising the step of orally administering to the human a composition that includes a therapeutically effective amount of at least one gamma-aminobutyric acid agonist.

2. The method of claim 1 , wherein the gamma-aminobutyric acid (GABA) agonist administered to the human is a GABA(B) agonist.

3. The method of claim 2 , wherein the GABA(B) agonist includes baclofen.

4. The method of claim 3 , wherein baclofen is R-baclofen.

5. The method of claim 3 , wherein the baclofen is administered to the human in a dose of at least one member selected from the group consisting of about 2.5 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 40 mg, about 45 mg, about 50 mg and about 100 mg.

6. The method of claim 3 , wherein the baclofen is administered in a single daily dose.

7. The method of claim 3 , wherein the baclofen is administered to the human in multiple daily doses.

8. The method of claim 7 , wherein the baclofen is administered to the human in at least one member selected from the group consisting of two daily doses, three daily doses, four daily doses and five daily doses.

9. The method of claim 3 , wherein the R-baclofen administered to the human includes at least one member selected from the group consisting of about 85 mole percent R-baclofen, at least about 90 mole percent R-baclofen, at least about 95 mole percent R-baclofen and at least about 99 mole percent R-baclofen.

10. The method of claim 9 , wherein the baclofen administered to the human is at least about 99 mole percent R-baclofen.

11. The method of claim 1 , wherein the human further has fragile X syndrome.

12. The method of claim 1 , further including administering a Group I mGluR antagonist to the human.

13. The method of claim 12 , wherein the mGluR antagonist includes a mGluR5 antagonist.

14. The method of claim 12 , wherein the mGluR antagonist includes a mGluR1 antagonist.

15. The method of claim 1 , wherein administering the gamma-aminobutyric acid agonist to the human further causes a decrease in at least one member selected from the group consisting of an obsessive compulsive disorder, a sensory hyperarousal disorder, an anxiety disorder, a seizure disorder, irritability, aggression, startle tremor, repetitive/self-stimulatory behavior, eye diversion, hand biting, hitting of the head, and hitting of others.

16. The method of claim 1 , wherein the improvement in the social domain following administration of the gamma-aminobutyric acid agonist to the human includes an increase in at least one member selected from the group consisting of an appropriate response to spoken language, spontaneous attempts to interact, eye contact, motivation and calmness.

17. The method of claim 1 , wherein administration of the gamma-aminobutyric acid agonist to the human further improves a communication domain in the human.

18. The method of claim 17 , wherein the improvement in the communication domain includes an improvement in verbal language.

19. The method of claim 1 , wherein the improvement in the social domain following administration of the gamma-aminobutyric acid agonist to the human further includes an improvement in mood.

20. A method of decreasing at least one member selected from the group consisting of irritability and aggression in a human having autism spectrum disorder, comprising the step of orally administering to the human a composition that includes a therapeutically effective amount at least one gamma-aminobutyric acid agonist.

21. The method of claim 20 , wherein the gamma-aminobutyric acid agonist is a GABA(B) agonist.

22. The method of claim 21 , wherein the GABA(B) agonist includes baclofen.

23. The method of claim 22 , wherein the baclofen is R-baclofen.

24. A method of improving a social domain in a human having autism spectrum disorder, comprising the step of orally administering to the human a composition that includes a therapeutically effective amount of at least about 99 mole percent R-baclofen in the composition.

25. The method of claim 24 , wherein the human administered the composition further has an improvement in a communication domain.

26. A method of improving a communication domain in a human having autism spectrum disorder, comprising the step of orally administering to the human a composition that includes a therapeutically effective amount of at least about 99 mole percent R-baclofen in the composition.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2014
From: SEASIDE THERAPEUTICS, INC.
To: CLINICAL RESEARCH ASSOCIATES, LLC
Reel/Frame 032076/0588 →
CHANGE OF NAME Recorded Feb 1, 2012
From: SEASIDE THERAPEUTICS, LLC
To: SEASIDE THERAPEUTICS, INC.
Reel/Frame 027635/0358 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2012
From: ROBERTS, KATHRYN; CARPENTER, RANDALL L.; BEAR, MARK F.
To: SEASIDE THERAPEUTICS, LLC
Reel/Frame 027628/0023 →
Continuity (5)
Continuation 12454202 · May 14, 2009
Continuation PCTUS2007024311 · Nov 21, 2007
Provisional Application 61001567 · Nov 2, 2007
Provisional Application 60860733 · Nov 22, 2006
Related Publication 20120129940A1 · May 24, 2012