# US 10,765,666 B2 · Use of gaboxadol for the treatment of Tourette syndrome, tics and stuttering

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- Number: US 10,765,666 B2
- Document ID: US10765666B2
- Status: Granted
- Kind: B2
- Application number: 16/577,084
- Filed: 2019-09-20
- Published: 2020-03-26
- Granted: 2020-09-08
- Earliest claimed: 2018-09-20
- Assignees: Ovid Therapeutics Inc.
- Applicants: Ovid Therapeutics Inc.
- Inventors: Matthew During
- Web page: https://patentgrep.com/patent/US10765666B2

## CPC

- A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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%.

### Claim 5 (depends on 1)

The method of claim 1, wherein the AUC6-12 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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 3)

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

### Claim 9 (depends on 1)

The method of claim 1, wherein the method provides an in vivo plasma profile of gaboxadol comprising a Cmax 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.

### Claim 10 (depends on 1)

The method of claim 1, wherein the method provides an in vivo plasma profile of gaboxadol comprising a AUC6-12 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.

### Claim 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.

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

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.

### Claim 14 (depends on 11)

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%.

### Claim 15 (depends on 11)

The method of claim 11, wherein the AUC6-12 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.

### Claim 16 (depends on 11)

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.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 13)

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

### Claim 19 (depends on 11)

The method of claim 11, wherein the method provides an in vivo plasma profile of gaboxadol comprising a Cmax 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.

### Claim 20 (depends on 11)

The method of claim 11, wherein the method provides an in vivo plasma profile of gaboxadol comprising a AUC6-12 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.