IP Library › Granted Patent US 12,226,464
Granted Patent B2
US 12,226,464 · App. 16/499,988 · Granted Feb 18, 2025

Compositions for treating addiction

Inventors: Joan M. Fallon (White Plains, NY); Matthew F. Heil (Sherman, CT)
Assignee: Curemark, LLC
A61K38/54A61K9/4808A61K9/4825A61K9/4891A61K9/5015A61P25/36A61K45/06
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Quick Facts
Patent No.
US 12,226,464
App. No.
16/499,988
Granted
Feb 18, 2025
Kind
B2
Abstract

A pharmaceutical composition for use in the treatment of the symptoms of an addiction is disclosed. The pharmaceutical composition contains, but is not limited to, digestive enzymes. The pharmaceutical composition may further contain a coating that surrounds a core of digestive enzymes in the form of coated particles. The pharmaceutical composition may also be encapsulated. The therapeutic agent may be manufactured by a variety of technologies.

Claims (37)

1. A method of reducing an elevated amount of ΔFos in a subject having an addiction, wherein ΔFos is elevated in the subject due to the addiction compared to a subject without the addiction, the method comprising: ¶

(a) selecting the subject to be treated when the subject is diagnosed with a blood level of phenylalanine of from 1 mg/dL to 3 mg/dL or with a blood level of phenylalanine of from 60 to 120 micromolar, and

(b) administering to the subject a therapeutically effective amount of a pharmaceutical composition that comprises digestive enzymes, wherein ΔFos is reduced upon administration of the pharmaceutical composition to the subject.

2. The method of claim 1 , wherein the digestive enzymes comprise an amylase, a lipase, and a protease.

3. The method of claim 1 , wherein the digestive enzymes in the pharmaceutical composition further comprise a lipid coating.

4. The method of claim 1 , wherein the pharmaceutical composition is encapsulated.

5. The method of claim 1 , wherein a dose of the pharmaceutical composition comprises about 4, about 5, about 6, about 7, about 8, or about 9 capsules, tablets, or sachets.

6. The method of claim 1 , wherein the addiction comprises a drug addiction, and wherein the drug comprises an opiate.

7. The method of claim 6 , wherein the opiate comprises a natural opiate, a synthetic opiate, or a combination thereof.

8. The method of claim 7 , wherein the opiate comprises the synthetic opiate, and wherein the synthetic opiate is selected from the group consisting of hydromorphone hydrochloride, meperidine, Oxycodone, hydrocodone and acetaminophen, Fentanyl, Methadone, and a combination thereof.

9. The method of claim 2 , wherein a total protease and a total lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to lipase of from about 1:1 to about 20:1.

10. The method of claim 2 , wherein a total protease and a total amylase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to amylase of from about 1:0.1 to about 1:10.

11. The method of claim 1 , wherein the pharmaceutical composition comprises coated digestive enzyme particles.

12. The method of claim 1 , wherein the pharmaceutical composition comprises coated digestive enzyme particles that are encapsulated.

13. The method of claim 11 , wherein the coated digestive enzyme particles comprise (i) a core that comprises the digestive enzymes, and (ii) a coating.

14. The method of claim 13 , wherein the coating comprises a lipid.

15. The method of claim 14 , wherein the lipid comprises a pharmaceutical grade lipid.

16. The method of claim 15 , wherein the pharmaceutical grade lipid comprises a fully-hydrogenated soybean oil.

17. The method of claim 14 , wherein the lipid comprises a hydrogenated lipid, a partially saturated lipid, or a combination thereof.

18. The method of claim 14 , wherein the lipid comprises a soy lipid.

19. The method of claim 18 , wherein the soy lipid comprises a hydrogenated soy lipid.

20. The method of claim 1 wherein the pharmaceutical composition is administered to the subject orally.

21. The method of claim 11 , wherein the coated digestive enzyme particles are encapsulated in a gelatin capsule or a hydroxypropyl methylcellulose (HPMC) capsule.

22. The method of claim 1 , wherein the subject is administered one or more doses of the pharmaceutical composition.

23. The method of claim 22 , wherein a dose of the pharmaceutical composition comprises from about 100 to about 9,000 mg of the digestive enzymes.

24. The method of claim 11 , wherein the digestive enzymes are present in the coated digestive enzyme particles in an amount of from about 70% to about 90% by weight, or from about 75% to about 85% by weight.

25. The method of claim 24 , wherein the digestive enzymes are present in the coated particles in an amount of about 75% by weight.

26. The method of claim 24 , wherein the digestive enzymes are present in the coated particles in an amount of about 77.5% by weight.

27. The method of claim 24 , wherein the digestive enzymes are present in the coated particles in an amount of about 80% by weight.

28. The method of claim 24 , wherein the digestive enzymes are present in the coated particles in an amount of about 82.5% by weight.

29. The method of claim 24 , wherein the digestive enzymes are present in the coated particles in an amount of about 85% by weight.

30. The method of claim 11 , wherein at least 90% of the coated particles are from about 105 μm to about 425 μm in size.

31. The method of claim 11 , wherein at least 75% of the coated particles are from about 180 μm to about 425 μm in size.

32. The method of claim 11 , wherein less than about 20% of the coated particles are capable of being sieved through about 150 μm mesh.

33. The method of claim 11 , wherein less than about 15% of the coated particles are capable of being sieved through about 150 μm mesh.

34. The method of claim 1 , wherein the ΔFos comprises ΔFosβ.

35. The method of claim 2 , wherein a dose of the pharmaceutical composition comprises from about 650,000 U.S.P. units to about 1.5×10 6 U.S.P. units of the protease.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 2, 2019
From: FALLON, JOAN M.; HEIL, MATTHEW F.
To: CUREMARK, LLC
Reel/Frame 050600/0894 →
Continuity (2)
Provisional Application 62483856 · Apr 10, 2017
Related Publication 20200101145A1 · Apr 2, 2020
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