IP Library Granted Patent US 10,765,666
Granted Patent B2
US 10,765,666 · App. 16/577,084 · Granted Sep 8, 2020

Use of gaboxadol for the treatment of Tourette syndrome, tics and stuttering

Inventor: Matthew During (Weston, CT)
Assignee: OVID THERAPEUTICS INC
A61K31/437A61P25/14
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Quick Facts
Patent No.
US 10,765,666
App. No.
16/577,084
Granted
Sep 8, 2020
Kind
B2
Abstract

Treatment of Tourette syndrome using gaboxadol or a pharmaceutically acceptable salt thereof is provided. Treatment of tics using gaboxadol or a pharmaceutically acceptable salt thereof is provided. Treatment of stuttering using gaboxadol or a pharmaceutically acceptable salt thereof is provided. Therapeutic compositions that may be used to improve one or more symptoms of Tourette syndrome are provided. Therapeutic compositions that may be used to improve one or more symptoms of tics are provided. Also provided are therapeutic compositions that may be used to improve one or more symptoms of stuttering.

Claims (20)

1. A method of treating Tourette syndrome comprising administering to a patient in need thereof about 0.05 mg to about 30 mg gaboxadol or a pharmaceutically acceptable salt thereof, wherein the method provides improvement in one or more symptoms of Tourette syndrome in the patient.

2. The method of claim 1 , wherein the improvement is provided for more than 6 hours after administration.

3. The method of claim 1 , wherein the patient is administered a composition comprising about 1 mg to about 15 mg gaboxadol or a pharmaceutically acceptable salt thereof.

4. The method of claim 1 , wherein the in vivo plasma profile of gaboxadol of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is reduced by more than 50%.

5. The method of claim 1 , wherein the AUC 6-12 of gaboxadol of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is less than 75% of the administered dose.

6. The method of claim 1 , wherein the method provides improvement in at least one symptom selected from the group consisting of simple tics, complex tics, and disabling tics.

7. The method of claim 6 , wherein simple tics are selected from the group consisting of eye blinking, eye movements, facial grimacing, shoulder shrugging, head or shoulder jerking, repetitive throat-clearing, sniffing, grunting and barking sounds; complex tics are selected from the group consisting of facial grimacing combined with a head twist, facial grimacing combined with a shoulder shrug, sniffing objects, touching objects, hopping, jumping, bending, twisting, uttering words and uttering phrases; and disabling tics are selected from the group consisting of self harm tics, coprolalia and echolalia.

8. The method of claim 3 , wherein the composition provides improvement in the patient for at least 12 hours.

9. The method of claim 1 , wherein the method provides an in vivo plasma profile of gaboxadol comprising a C max less than about 400 ng/ml and wherein the method provides improvement in the patient for more than 6 hours after administration of the gaboxadol or a pharmaceutically acceptable salt thereof.

10. The method of claim 1 , wherein the method provides an in vivo plasma profile of gaboxadol comprising a AUC 6-12 of less than about 900 ng·hr/ml and wherein the method provides improvement in the patient for more than 6 hours after administration of the gaboxadol or a pharmaceutically acceptable salt thereof.

11. A method of treating tics comprising administering to a patient in need thereof about 0.05 mg to about 30 mg gaboxadol or a pharmaceutically acceptable salt thereof, wherein the method provides improvement in one or more symptoms of the tics in the patient.

12. The method of claim 11 , wherein the improvement is provided for more than 6 hours after administration.

13. The method of claim 11 , wherein the patient is administered a composition comprising about 1 mg to about 15 mg gaboxadol or a pharmaceutically acceptable salt thereof.

14. The method of claim 11 , wherein the in vivo plasma profile of gaboxadol of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is reduced by more than 50%.

15. The method of claim 11 , wherein the AUC 6-12 of gaboxadol of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is less than 75% of the administered dose.

16. The method of claim 11 , wherein the method provides improvement in at least one symptom selected from the group consisting of simple tics, complex tics, and disabling tics.

17. The method of claim 16 , wherein simple tics are selected from the group consisting of eye blinking, eye movements, facial grimacing, shoulder shrugging, head or shoulder jerking, repetitive throat-clearing, sniffing, grunting and barking sounds; complex tics are selected from the group consisting of facial grimacing combined with a head twist, facial grimacing combined with a shoulder shrug, sniffing objects, touching objects, hopping, jumping, bending, twisting, uttering words and uttering phrases; and disabling tics are selected from the group consisting of self harm tics, coprolalia and echolalia.

18. The method of claim 13 , wherein the composition provides improvement in the patient for at least 12 hours.

19. The method of claim 11 , wherein the method provides an in vivo plasma profile of gaboxadol comprising a C max less than about 400 ng/ml and wherein the method provides improvement in the patient for more than 6 hours after administration of the gaboxadol or a pharmaceutically acceptable salt thereof.

20. The method of claim 11 , wherein the method provides an in vivo plasma profile of gaboxadol comprising a AUC 6-12 of less than about 900 ng·hr/ml and wherein the method provides improvement in the patient for more than 6 hours after administration of the gaboxadol or a pharmaceutically acceptable salt thereof.

Assignments (2)
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY NAME PREVIOUSLY RECORDED AT REEL: 52975 FRAME: 390. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 3, 2020
From: DURING, MATTHEW
To: OVID THERAPEUTICS INC.
Reel/Frame 053383/0414 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2020
From: DURING, MATTHEW
To: OVID THEREAPEUTICS INC
Reel/Frame 052975/0390 →
Continuity (2)
Provisional Application 62733730 · Sep 20, 2018
Related Publication 20200093806A1 · Mar 26, 2020