# US 12,599,581 B2 · Method of treating expressive language deficit in autistic humans

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- Number: US 12,599,581 B2
- Document ID: US12599581B2
- Status: Granted
- Kind: B2
- Application number: 18/621,580
- Filed: 2024-03-29
- Published: 2024-07-25
- Granted: 2026-04-14
- Earliest claimed: 2022-06-11
- Assignees: AMS Therapeutics, LLC
- Applicants: AMS Therapeutics, LLC
- Inventors: Charles E. Niesen
- Web page: https://patentgrep.com/patent/US12599581B2

## CPC

- A61K 31/4015: having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/08: Antiepileptics; Anticonvulsants
- 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

A pharmacological method for treating the expressive language deficit in an autistic human child or adult is provided. A therapeutically effective dose of a succinimide anticonvulsant, e.g., ethosuximide, methsuximide, phensuximide, or a pharmaceutically acceptable salt thereof, is administered to a patient suffering from expressive language deficit, preferably over an extended period, e.g., six months or longer. Language gains are retained even after treatment is discontinued.

## Claims

### Claim 1

A method of treating expressive language deficit in an autistic, nonepileptic, adult human, comprising:
administering ethosuximide to the autistic, nonepileptic, adult human at a dosage and for a period of time sufficient to reduce the adult human's expressive language deficit; wherein the dosage is at least 500 mg/day and the period of time is at least three months.

### Claim 2 (depends on 1)

The method of claim 1, wherein the period of time is at least six months.

### Claim 3 (depends on 1)

The method of claim 1, wherein the dosage is at least 250 mg b.i.d.

### Claim 4 (depends on 1)

The method of claim 1, wherein the dosage is at least 500 mg b.i.d.

### Claim 5 (depends on 2)

The method of claim 2, wherein the dosage is at least 375 mg b.i.d.

### Claim 6 (depends on 1)

The method of claim 1, wherein the ethosuximide is administered twice per day.

### Claim 7 (depends on 1)

The method of claim 1, wherein the ethosuximide is administered orally.

### Claim 8 (depends on 1)

The method of claim 1, wherein the dosage and period of time are sufficient to raise the adult human's expressive language skills by at least 1 point on a 7-point scale, where 0=non-verbal, 1=echolalic, 2=single words, 3=phrases, 4=sentences, 5=spontaneous speech, and 6=mutual speech (true conversation with another person).

### Claim 9 (depends on 8)

The method of claim 8, wherein the ethosuximide is administered for a period of time sufficient to raise the adult human's expressive language skills by at least 1.5 points.

### Claim 10 (depends on 8)

The method of claim 8, wherein the ethosuximide is administered for a period of time sufficient to raise the adult human's expressive language skills by at least 2 points.