# US 2021/0275540 A1 · Treatment of tourette's syndrome with ecopipam

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- Number: US 2021/0275540 A1
- Document ID: US20210275540A1
- Status: Published application
- Kind: A1
- Application number: 17/327,465
- Filed: 2021-05-21
- Published: 2021-09-09
- Earliest claimed: 2012-07-12
- Assignees: Emalex Biosciences, Inc.
- Applicants: Emalex Biosciences, Inc.
- Inventors: Richard E. Chipkin; Rudolf Kwan
- Web page: https://patentgrep.com/patent/US20210275540A1

## CPC

- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 31/04: Antibacterial agents
- A61P 37/02: Immunomodulators
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

The present invention encompasses methods of treating a subject who has been diagnosed as having a tic disorder or a movement disorder. The tic disorder can be Tourette's Syndrome, and the methods can include the steps of: (a) identifying a subject in need of treatment; and (b) administering to the subject a therapeutically effective amount of a composition comprising a D1/D5 receptor antagonist, a D1/D5 receptor partial agonist, or a mixture thereof. For example, the D1/D5 receptor antagonist can be ecopipam or a pharmaceutically acceptable salt, solvate, hydrate, prodrug, structural analog, metabolite, or polymorph thereof.

## Claims

### Claim at position 1

-20. (canceled)

### Claim 21

A method of treating Tourette's Disorder in a human patient, comprising administering to the patient a dose of ecopipam or a pharmaceutically acceptable salt thereof in a range of 0.1 mg/kg body weight to 5 mg/kg body weight per day.

### Claim 22 (depends on 21)

The method of claim 21, wherein the dose is in a range of 1 mg/kg body weight to 5 mg/kg body weight per day of ecopipam or pharmaceutically acceptable salt thereof.

### Claim 23 (depends on 22)

The method of claim 22, wherein the dose is about 2 mg/kg body weight of ecopipam or pharmaceutically acceptable salt thereof.

### Claim 24 (depends on 21)

The method of claim 21, wherein the ecopipam or pharmaceutically acceptable salt thereof comprises ecopipam hydrochloride.

### Claim 25 (depends on 21)

The method of claim 21, wherein the ecopipam or pharmaceutically acceptable salt thereof is administered orally.

### Claim 26 (depends on 25)

The method of claim 25, wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated in a unit dosage form.

### Claim 27 (depends on 26)

The method of claim 26, wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated as a capsule, tablet, pill, powder, or syrup.

### Claim 28 (depends on 21)

The method of claim 21, wherein the dose of ecopipam or pharmaceutically acceptable salt thereof per day is administered once daily, or in divided doses twice or three times daily.

### Claim 29 (depends on 28)

The method of claim 28, wherein the dose of ecopipam or pharmaceutically acceptable salt thereof is administered once daily.

### Claim 30 (depends on 21)

The method of claim 21, wherein the patient is not older than 18 years.

### Claim 31 (depends on 21)

The method of claim 21, wherein the patient is free from one or more conditions in the group of attention-deficit-hyperactivity disorder, depression, and obsessive-compulsive disorder.

### Claim 32 (depends on 21)

The method of claim 21, wherein the patient is free from attention-deficit-hyperactivity disorder, depression, and obsessive-compulsive disorder

### Claim 33 (depends on 21)

The method of claim 21, further comprising a step of administering a second treatment for treating the tic disorder

### Claim 34 (depends on 33)

The method of claim 33, wherein the second treatment is a behavioral, surgical, or pharmaceutical therapy

### Claim 35 (depends on 21)

The method of claim 21, further comprising a step of administering to the subject a therapeutically effective amount of a second composition for the treatment of one or more conditions chosen from attention-deficit-hyperactivity disorder, depression, and obsessive-compulsive disorder.

### Claim 36 (depends on 21)

The method of claim 21, wherein the administration is in the absence of an environmental modification comprising a trigger.

### Claim 37

A method of treating Tourette's Disorder in a human patient, comprising administering to the patient a dose of ecopipam or a pharmaceutically acceptable salt thereof in a range of 50 mg to 500 mg per day.

### Claim 38 (depends on 37)

The method of claim 37, wherein the dose is in a range of 50 mg to 350 mg per day of ecopipam or pharmaceutically acceptable salt thereof.

### Claim 39 (depends on 38)

The method of claim 38, wherein the dose is in a range of 50 mg to 250 mg per day of ecopipam or pharmaceutically acceptable salt thereof.

### Claim 40 (depends on 37)

The method of claim 37, wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated in a unit dosage form.

### Claim 41 (depends on 40)

The method of claim 40, wherein the unit dosage form comprises the ecopipam or pharmaceutically acceptable salt thereof in a range of 30 mg to 40 mg.

### Claim 42 (depends on 40)

The method of claim 40, wherein the unit dosage form comprises the ecopipam or pharmaceutically acceptable salt thereof in a range of 50 mg to 100 mg.

### Claim 43 (depends on 40)

The method of claim 40, wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated as a capsule, tablet, pill, powder, or syrup.

### Claim 44 (depends on 37)

The method of claim 37, wherein the dose of ecopipam or pharmaceutically acceptable salt thereof per day is administered once daily, or in divided doses twice or three times daily.

### Claim 45 (depends on 44)

The method of claim 44, wherein the dose of ecopipam or pharmaceutically acceptable salt thereof is administered once daily.

### Claim 46 (depends on 37)

The method of claim 37, wherein the ecopipam or pharmaceutically acceptable salt thereof comprises ecopipam hydrochloride.

### Claim 47 (depends on 37)

The method of claim 37, wherein the ecopipam or pharmaceutically acceptable salt thereof is administered orally.

### Claim 48 (depends on 37)

The method of claim 37, wherein the patient is not older than 18 years.

### Claim 49 (depends on 37)

The method of claim 37, wherein the administration is in the absence of an environmental modification comprising a trigger.

### Claim 50

A method of treating Tourette's Disorder in a human patient not older than 18 years, comprising administering to the patient once daily oral dosages of ecopipam or a pharmaceutically acceptable salt thereof at a daily dose in a range of about 1 mg/kg body weight to about 5 mg/kg body weight.