IP Library Granted Patent US 12,144,796
Granted Patent B2
US 12,144,796 · App. 18/127,612 · Granted Nov 19, 2024

Formulations for treating cluster symptoms associated with autism spectrum disorder

Inventors: Oludare Odumosu (Newtown Square, PA); Erica Daniels (Newtown Square, PA); Zachary Swope (Newtown Square, PA); Megan Watkins (Newtown Square, PA)
Assignee: Hera Therapeutics LLC
A61K31/352A61K31/015A61K31/045A61K31/05A61P25/22
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Quick Facts
Patent No.
US 12,144,796
App. No.
18/127,612
Granted
Nov 19, 2024
Kind
B2
Abstract

The present disclosure provides for pharmaceutical compositions useful for treating autism spectrum disorder. The pharmaceutical compositions comprise particular THC:CBD ratios and terpene profiles, which have been demonstrated effective at treating cluster symptoms associated with autism spectrum disorder.

Claims (21)

1. A method of reducing agitation in a patient with autism spectrum disorder (ASD), said method comprising administering a pharmaceutical composition to the patient, wherein the pharmaceutical composition comprises:

(a) a Cannabinoid Profile comprising Tetrahydrocannabinol (THC) and Cannabidiol (CBD) at a THC: CBD ratio of 1:1 by weight; and

(b) a Terpene Profile comprising a-Pinene, Valencene, and Eucalyptol.

2. The method of claim 1 , wherein the Terpene Profile comprises 25%-35% α-Pinene by weight, 25%-35% Valencene by weight, and 30%-40% Eucalyptol by weight, wherein the total of % α-Pinene+ % Valencene+ % Eucalyptol=100%.

3. The method of claim 1 , wherein the pharmaceutical composition comprises about 31% α-Pinene by weight, about 31% Valencene by weight, and about 37.5% Eucalyptol by weight.

4. The method of claim 1 , wherein the ratio of the Cannabinoid Profile to Terpene Profile is between 10:1 and 5:1 by weight.

5. The method of claim 1 , wherein the pharmaceutical composition is peppermint flavored.

6. The method of claim 1 , wherein the pharmaceutical composition is vanilla flavored.

7. The method of claim 1 , wherein the pharmaceutical composition is lemon flavored.

8. The method of claim 1 , wherein the pharmaceutical composition is orange flavored.

9. The method of claim 1 , wherein the pharmaceutical composition is ginger flavored.

10. The method of claim 1 , wherein the pharmaceutical composition is passionfruit flavored.

11. The method of claim 1 , wherein the pharmaceutical composition further comprises olive oil.

12. The method of claim 1 , wherein the pharmaceutical composition is formulated for oral administration.

13. The method of claim 1 , wherein the pharmaceutical composition is formulated as a liquid dose.

14. The method of claim 13 , wherein the liquid dose is about 2.5 mL.

15. The method of claim 13 , wherein the liquid dose is about 5 mL.

16. The method of claim 1 , wherein the total amount of CBD and THC in the pharmaceutical composition is 300 mg.

17. The method of claim 1 , wherein the pharmaceutical composition comprises from 125 mg to 175 mg of CBD.

18. The method of claim 1 , wherein the pharmaceutical composition comprises from 125 mg to 175 mg of THC.

19. The method of claim 1 , wherein the pharmaceutical composition comprises about 5 mg/mL THC, about 5 mg/mL CBD, about 0.43 mg/mL a-pinene, about 0.43 mg/mL valencene, and about 0.5 mg/mL eucalyptol.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 4, 2023
From: ODUMOSU, OLUDARE; DANIELS, ERICA; SWOPE, ZACHARY; WATKINS, MEGAN
To: ILERA THERAPEUTICS LLC
Reel/Frame 063218/0574 →
Continuity (5)
Continuation 17468023 · Sep 7, 2021
Continuation PCTUS2020021767 · Mar 9, 2020
Provisional Application 62852513 · May 24, 2019
Provisional Application 62815236 · Mar 7, 2019
Related Publication 20240066005A1 · Feb 29, 2024