# US 10,765,646 B2 · Methods of treating developmental encephalopathies

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- Number: US 10,765,646 B2
- Document ID: US10765646B2
- Status: Granted
- Kind: B2
- Application number: 15/951,580
- Filed: 2018-04-12
- Published: 2018-10-18
- Granted: 2020-09-08
- Earliest claimed: 2017-04-13
- Assignees: Ovid Therapeutics Inc.
- Applicants: Ovid Therapeutics Inc.
- Inventors: Matthew During
- Web page: https://patentgrep.com/patent/US10765646B2

## CPC

- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 9/0043: {Nose}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2077: {Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets}
- A61K 9/2081: {with microcapsules or coated microparticles according to A61K9/50}
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- 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

Methods of treating developmental encephalopathies by administering compositions including ketamine, norketamine, or other derivatives of ketamine, or a pharmaceutically acceptable salt of any of the foregoing, are provided. The methods and compositions may be used to treat conditions such as Dravet syndrome.

## Claims

### Claim 1

A method of treating Lennox-Gastaut syndrome (LGS) comprising intranasally administering to a patient in need thereof a pharmaceutical composition comprising S-ketamine or a pharmaceutically acceptable salt thereof in an amount ranging from about 1 mg to about 100 mg.

### Claim 2 (depends on 1)

The method of claim 1 wherein the S-ketamine or the pharmaceutically acceptable salt thereof is administered at a dosage selected from the group consisting of about 10 mg, 20 mg, 28 mg, 40 mg, 56 mg, 80 mg and 84 mg.

### Claim 3 (depends on 2)

The method of claim 2 wherein the S-ketamine or the pharmaceutically acceptable salt thereof is administered at a dosage of about 28 mg.

### Claim 4 (depends on 1)

The method of claim 1 wherein the pharmaceutically acceptable salt thereof is an acid addition salt.

### Claim 5 (depends on 4)

The method of claim 4 wherein the acid addition salt is S-ketamine hydrochloride.

### Claim 6 (depends on 5)

The method of claim 5 wherein the S-ketamine hydrochloride is administered at a dosage of about 32.3 mg.

### Claim 7 (depends on 1)

The method of claim 1, wherein administration of the composition comprising S-ketamine or the pharmaceutically acceptable salt thereof provides an in vivo plasma profile comprising a Cmax less than about 38 ng/ml.

### Claim 8 (depends on 1)

The method of claim 1 wherein the S-ketamine or the pharmaceutically acceptable salt thereof is administered once daily.

### Claim 9 (depends on 1)

The method of claim 1 wherein the S-ketamine or the pharmaceutically acceptable salt thereof is administered once weekly.

### Claim 10 (depends on 1)

The method of claim 1 wherein the S-ketamine or the pharmaceutically acceptable salt thereof is administered twice weekly.

### Claim 11 (depends on 1)

The method of claim 1 wherein the amount of the S-ketamine or the pharmaceutically acceptable salt thereof is administered in an amount ranging from about 0.1 mg/kg and about 10 mg/kg of body weight of the patient.

### Claim 12 (depends on 1)

The method of claim 1, wherein administration of the composition comprising S-ketamine or the pharmaceutically acceptable salt thereof provides an in vivo plasma profile comprising an AUC0-∞ less than about 200 ng·hr/ml.