# US 2026/0076984 A1 · Treatment of behavioral impairment in developmental and epileptic encephalopathy

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- Number: US 2026/0076984 A1
- Document ID: US20260076984A1
- Status: Published application
- Kind: A1
- Application number: 19/399,173
- Filed: 2025-11-24
- Published: 2026-03-19
- Earliest claimed: 2019-09-18
- Assignees: Harmony Biosciences Management, Inc.
- Applicants: Harmony Biosciences Management, Inc.
- Inventors: Terri Sebree; Donna Gutterman; John Messesnheimer
- Web page: https://patentgrep.com/patent/US20260076984A1

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 38/1709: {from mammals}
- A61M 21/02: for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia (for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021)
- 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
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- C07K 16/2803: {against the immunoglobulin superfamily}
- A61K 2039/505: {comprising antibodies}
- A61M 2021/0077: {with application of chemical or pharmacological stimulus}
- C07K 2317/31: multispecific
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12Q 1/6869: Methods for sequencing
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## 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

### Claim 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.

### Claim 2 (depends on 1)

The method of claim 1, wherein treatment includes a meaningful 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.

### Claim 3 (depends on 1)

The method according to claim 1, wherein treatment includes a meaningful 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.

### Claim 4 (depends on 1)

The method according to claim 1, wherein treatment includes a meaningful improvement in adaptive behavior as determined by a decrease in the Vineland Adaptive Behavior Scale™-3 (VABS-3) within one month or two months.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

The method according to claim 1, wherein the subject has Lennox-Gastaut or Dravet Syndrome and is a 50% responder within 30 days.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

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

### Claim 15 (depends on 1)

The method according to claim 1, wherein the CBD is botanically derived.

### Claim 16 (depends on 15)

The method of claim 15, wherein the CBD is purified.

### Claim 17 (depends on 1)

The method according to claim 1, wherein subject having developmental and epileptic encephalopathy (DEE) comprises the subject having SYNGAP1 encephalopathy.