# US 12,213,951 B2 · Treatment of autism with cannabidiol

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- Number: US 12,213,951 B2
- Document ID: US12213951B2
- Status: Granted
- Kind: B2
- Application number: 18/124,460
- Filed: 2023-03-21
- Published: 2023-11-16
- Granted: 2025-02-04
- Earliest claimed: 2017-09-28
- Assignees: Harmony Biosciences Management, Inc.
- Applicants: Harmony Biosciences Management, Inc.
- Inventors: Terri Sebree; Marcel Bonn-Miller; Donna Gutterman
- Web page: https://patentgrep.com/patent/US12213951B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 36/3482: {Cannabis}
- A61P 25/00: Drugs for disorders of the nervous system
- 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 technology relates to a method of treating one or more behavioral symptoms of Autism Spectrum Disorder (ASD) in a subject by transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein one or more behavioral symptoms of ASD are treated in the subject.

## Claims

### Claim 1

A method of treating a human suffering from an autism spectrum disorder comprising:
transdermally administering via a gel or cream a therapeutically effective amount of purified cannabidiol to the human suffering from the autism spectrum disorder to effectively treat the autism spectrum disorder in the human in need thereof,
wherein the gel or cream is administered to the upper arm.

### Claim 2 (depends on 1)

The method of claim 1, wherein the cannabidiol is (-)-cannabidiol.

### Claim 3 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of cannabidiol is 250 mg total daily.

### Claim 4 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of cannabidiol is 500 mg total daily.

### Claim 5 (depends on 1)

The method of claim 1, wherein the cannabidiol is formulated as a permeation-enhanced gel.

### Claim 6 (depends on 1)

The method of claim 1, wherein the cannabidiol is administered in a single-daily dose.

### Claim 7 (depends on 1)

The method of claim 1, wherein the cannabidiol is administered in two daily doses.

### Claim 8 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of cannabidiol is between about 50 mg to 500 mg total daily.