WO2019064234A1 – April 4, 2019 – TREATMENT OF FRAGILE X SYNDROME WITH CANNABIDIOL

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Inventors :

BONN-MILLER, Marcel - 1112 Riverwood Road, Lexington, NC 27292; TICH, Nancy - 8 Ashland Terrace, Chester, NJ 07930; GUTTERMAN, Donna - 10409 Veasey Mill Road, Raleigh, NC 27615; MESSENHEIMER, John - 55 Hermitage Lane, Moncure, NC 27599; SEBREE, Terri - 922 Merion Square Road, Gladwyne, PA 19035

Owner :

ZYNERBA PHARMACEUTICALS, INC.

Application Number :

WOIB18057519

Document Number :

WO2019064234A1

Priority Date :

January 1, 1970

Filing Date :

September 27, 2018

Date of Grant/ Publication :

April 4, 2019

Class :

; A61K31 / 05; A61P25 / 00

Abstract

The present technology relates to a method of treating one or more behavioral symptoms of Fragile X Syndrome in a subject by transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein one or more behavioral symptoms of Fragile X Syndrome are treated in the subject.

Claim(s)

1. A method of treating one or more behavioral symptoms of Fragile X Syndrome in a subject, the method comprising: transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein one or more behavioral symptoms of Fragile X Syndrome are treated in the subject.;
2. The method of claim 1, wherein the CBD is (-)- CBD.;
3. The method of claim 1, wherein the effective amount of CBD is between about 50 mg and about 500 mg total daily.;
4. The method of claim 1 , wherein the effective amount of CBD is initiated at 50 mg daily and titrated up to 500 mg daily.;
5. The method of claim 1, wherein the effective amount of CBD is initiated at 50 mg daily and titrated up to 250 mg daily.;
6. The method of claim 1, wherein the effective amount of CBD is initiated at 250 mg daily.;
7. The method of claim 1, wherein the effective amount of CBD is initiated at 500 mg daily.;
8. The method of claim 1, wherein the CBD is formulated as a gel.;
9. The method of claim 8, wherein the CBD is formulated as a permeation-enhanced gel.;
10. The method of claim 1, wherein the CBD is administered in a single daily dose.;
11. The method of claim 1, wherein the CBD is administered in two daily doses.;
12. The method of claim 1, wherein alleviating one or more behavioral symptoms of Fragile X Syndrome comprises an improvement in a total score of an Anxiety, Depression and Mood Scale (ADAMS).;
13. The method of claim 1, wherein alleviating one or more behavioral symptoms of Fragile X Syndrome comprises an improvement in one or more measures of an Aberrant Behavior Checklist for Fragile X (ABC-FXS).;
14. The method of claim 1, wherein the one or more behavioral symptoms is selected from the group consisting of general anxiety, social avoidance, compulsive behavior, manic/hyperactive behavior, irritability, lethargy, stereotypy, and inappropriate speech.;
15. The method of claim 1, wherein the behavioral symptom that is alleviated is general anxiety.;
16. The method of claim 1, wherein the behavioral symptom that is alleviated is social avoidance.;
17. The method of claim 1, wherein the behavioral symptom that is alleviated is compulsive behavior.;
18. The method of claim 1, wherein the behavioral symptom that is alleviated is manic/hyperactive behavior.;
19. The method of claim 1, wherein the behavioral symptom that is alleviated is irritability.;
20. The method of claim 1 , wherein the behavioral symptom that is alleviated is lethargy.;
claim 21: 21. The method of claim 1, wherein the behavioral symptom that is alleviated is unresponsiveness.;
claim 22: 22. The method of claim 1, wherein the behavioral symptom that is alleviated is stereotypy.;
claim 23: 23. The method of claim 1, wherein the behavioral symptom that is alleviated is inappropriate speech.;
claim 24: 24. The method of claim 1 , wherein the behavioral symptom that is alleviated is tantrum/mood liability.;
claim 25: 25. The method of claim 1, wherein the behavioral symptom that is alleviated is hyperactivity/impulsivity.;
claim 26: 26. The method of claim 1, wherein the CBD is transdermally administered on the subject’s arm.;
claim 27: 27. The method of claim 1, wherein the CBD is a synthetic CBD.;
claim 28: 28. The method of claim 1, wherein the CBD is a purified CBD.;
claim 29: 29. The method of claim 1, wherein the CBD is botanic ally derived.;
claim 30: 30. The method of claim 1 , wherein transdermally administering an effective amount of cannabidiol (CBD) reduces an intensity of at least one adverse event relative to orally administering CBD.;
claim 31: 31. The method of claim 30, wherein the at least one adverse event is selected from the group consisting of somnolence, psychoactive effects, liver function, and GI related adverse events.

Summary

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