Granted Patent
B2
US 12,582,664 · App. 17/970,395 · Granted Mar 24, 2026
Treatment of fragile x syndrome with cannabidiol
Inventors:
Joseph Palumbo (Saint Davids, PA); Stephen V. O'Quinn (Wake Forest, NC); Terri Sebree (Gladwyne, PA); Marcel Bonn-Miller (Lexington, NC); Donna Gutterman (Raleigh, NC)
Assignee:
Harmony Biosciences Management, Inc.
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Abstract
The present technology relates to a method of treating one or more behavioral symptoms of autism spectrum disorder (ASD) in a subject by administering an effective amount of cannabidiol (CBD). Specifically, subjects having moderate to severe ASD and relatively high social avoidance and/or anxiety are more likely to show a reduction in irritability when treated with CBD.
Claims (15)
1 . A method of treating a human suffering from moderate to severe 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.
2 . The method according to claim 1 , wherein the human has a baseline ABC-C irritability score of greater than 12.
3 . The method according to claim 1 , wherein the human has a baseline ABC-C FXS social avoidance score of greater than 5.
4 . The method according to claim 1 , wherein the human has a baseline Parent Rated Anxiety Scale for ASD (PRAS-ASD) score of greater than 25.
5 . The method according to claim 1 , wherein the human is diagnosed with moderate to severe ASD.
6 . The method according to claim 1 , wherein the human has an Autism Diagnostic Observation Schedule, 2 nd Edition (ADOS-2) comparison score of greater than or equal to 3.
7 . The method according to claim 1 , wherein the CBD is administered transdermally.
8 . The method according to claim 1 , wherein the CBD is synthetic CBD.
9 . The method according to claim 1 , wherein the effective amount of CBD is a 250 mg total daily dose.
10 . The method according to claim 1 , wherein the effective amount of CBD is a 500 mg total daily dose.
11 . The method according to claim 1 , wherein the effective amount of CBD is a 750 mg total daily dose.
12 . The method according to claim 1 , wherein the effective amount of CBD is a 1000 mg total daily dose.
13 . The method according to claim 1 , wherein the effective amount is administered in two daily doses.
14 . The method according to claim 1 , wherein the CBD is administered in a pharmaceutically acceptable preparation that does not contain THC.
15 . The method according to claim 1 , wherein the human is also diagnosed with Fragile X Syndrome (FXS).
Assignments (3)
SUPPLEMENTAL CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS
Recorded May 18, 2026
From: HARMONY BIOSCIENCES MANAGEMENT, INC. (F/K/A ZYNERBA PHARMACEUTICALS, INC.)
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 075642/0639 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 12, 2025
From: PALUMBO, JOSEPH; O'QUINN, STEPHEN V.; SEBREE, TERRI; BONN-MILLER, MARCEL; GUTTERMAN, DONNA
To: ZYNERBA PHARMACEUTICALS, INC.
Reel/Frame 072241/0683 →
CHANGE OF NAME
Recorded Sep 12, 2025
From: ZYNERBA PHARMACEUTICALS, INC.
To: HARMONY BIOSCIENCES MANAGEMENT, INC.
Reel/Frame 072870/0552 →
Continuity (9)
Continuation
16144632
· Sep 27, 2018
Provisional Application
63271015
· Oct 22, 2021
Provisional Application
62632532
· Feb 20, 2018
Provisional Application
62564834
· Sep 28, 2017
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