IP Library › Granted Patent US 12,508,270
Granted Patent B2
US 12,508,270 · App. 17/697,629 · Granted Dec 30, 2025

Treatment of behavioral impairment in developmental and epileptic encephalopathy

Inventors: Terri Sebree (Gladwyne, PA); Donna Gutterman (Raleigh, NC); John Messenheimer (Moncure, NC)
Assignee: Harmony Biosciences Management, Inc.
A61K31/658A61M21/02A61P25/08A61P25/28A61M2021/0077
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Quick Facts
Patent No.
US 12,508,270
App. No.
17/697,629
Granted
Dec 30, 2025
Kind
B2
Abstract

The present technology relates to methods of treating behavioral problems and seizures in a subject having developmental and epileptic encephalopathy (DEE) by transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein behavioral problems are treated in the subject.

Claims (16)

1 . A method of treating behavioral problems and seizures in a subject having developmental and epileptic encephalopathy (DEE), the method comprising:

transdermally administering an effective amount of cannabidiol (CBD) to the subject, wherein behavioral problems are treated in the subject; and

wherein the seizures treated are focal impaired awareness seizures (FIAS).

2 . The method of claim 1 , wherein treatment includes an improvement in quality of life as measured by an improvement in the Epilepsy and Learning Disabilities Quality of Life (ELDQOL) scale within 2 weeks, 4 weeks, or 8 weeks.

3 . The method according to claim 1 , wherein treatment includes a decrease in sleep disturbance as determined by an improvement of the Sleep Disturbance Scale for Children (SDSC) within 2 weeks, 4 weeks, or 8 weeks.

4 . The method according to claim 1 , wherein treatment includes an improvement in adaptive behavior as determined.

5 . The method according to claim 1 , wherein treatment includes an improvement in caregiver stress as measured by an improvement the University of Washington Caregiver Stress Scale within 2 weeks, 4 weeks, or 8 weeks.

6 . The method according to claim 1 , wherein treatment includes an improvement in every day satisfaction and well-being.

7 . The method according to claim 1 , wherein treatment includes an improvement in cognition and awareness.

8 . The method according to claim 1 , wherein the subject has no erythema or minimal erythema.

9 . The method according to claim 1 , wherein the treatment includes a monthly reduction in focal impaired awareness seizures and convulsive seizures.

10 . The method according to claim 1 , wherein the effective amount of CBD is 250, 500, 750, or 1000 mg total daily.

11 . The method according to claim 1 , wherein the CBD is administered in a single daily dose.

12 . The method according to claim 1 , wherein the CBD is administered in two daily doses.

13 . The method according to claim 1 , wherein the CBD is a synthetic CBD.

14 . The method according to claim 1 , wherein the DEE is Lennox-Gastaut Syndrome.

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 →
CHANGE OF NAME Recorded Nov 19, 2025
From: ZYNERBA PHARMACEUTICALS, INC.
To: HARMONY BIOSCIENCES MANAGEMENT, INC.
Reel/Frame 073604/0864 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2022
From: SEBREE, TERRI; GUTTERMAN, DONNA; MESSENHEIMER, JOHN
To: ZYNERBA PHARMACEUTICALS, INC.
Reel/Frame 059549/0890 →
Continuity (3)
Continuation PCTUS2020051102 · Sep 16, 2020
Provisional Application 62901651 · Sep 17, 2019
Related Publication 20220218625A1 · Jul 14, 2022
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