# US 2025/0367271 A1 · Compositions for treating addiction

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- Number: US 2025/0367271 A1
- Document ID: US20250367271A1
- Status: Published application
- Kind: A1
- Application number: 19/021,940
- Filed: 2025-01-15
- Published: 2025-12-04
- Earliest claimed: 2017-04-10
- Assignees: Curemark, LLC
- Applicants: Curemark, LLC
- Inventors: Joan M. Fallon; Matthew F. Heil
- Web page: https://patentgrep.com/patent/US20250367271A1

## CPC

- A61K 38/54: Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)}
- A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)}
- A61K 9/5015: {Organic compounds, e.g. fats, sugars}
- A61P 25/30: for treating abuse or dependence
- A61P 25/36: Opioid-abuse
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 1

(canceled)

### Claim 2

(canceled)

### Claim 3

A method of reducing an elevated amount of ΔFos in a subject having an addiction, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition that comprises digestive enzymes, wherein ΔFos is elevated in the subject due to the addiction compared to a subject without the addiction.

### Claim 4

A method of decreasing an amount or a length of dendritic spines in nerve cells of a subject having an addiction, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition that comprises digestive enzymes, thereby decreasing the amount or the length of the dendritic spines in nerve cells of the subject to an amount that is lower than prior to administration of the pharmaceutical composition.

### Claim 5 (depends on 4)

The method of claim 4, wherein the digestive enzymes comprise an amylase, a lipase, and a protease.

### Claim at position 6

6-9. (canceled)

### Claim 10 (depends on 4)

The method of claim 4, 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.

### Claim at position 8

11-13. (canceled)

### Claim 14 (depends on 4)

The method of claim 4, wherein the addiction comprises a drug addiction, wherein the drug comprises an opiate.

### Claim 15

(canceled)

### Claim 16 (depends on 14)

The method of claim 14, wherein the opiate comprises a natural opiate, a synthetic opiate, or a combination thereof.

### Claim at position 12

17-20. (canceled)

### Claim 21 (depends on 4)

The method of claim 4, wherein the addiction comprises an alcohol addiction.

### Claim at position 14

22-29. (canceled)

### Claim 30 (depends on 4)

The method of claim 4, wherein the pharmaceutical composition comprises coated digestive enzyme particles.

### Claim 31

(canceled)

### Claim 32 (depends on 30)

The method of claim 30, wherein the coated digestive enzyme particles comprise (i) a core that comprises the digestive enzymes and (ii) a coating.

### Claim 33 (depends on 32)

The method of claim 32, wherein the coating comprises an enteric coating.

### Claim 34 (depends on 32)

The method of claim 32, wherein the coating comprises a lipid.

### Claim 35

(canceled)

### Claim 36

(canceled)

### Claim 37 (depends on 34)

The method of claim 34, wherein the lipid comprises a pharmaceutical grade lipid.

### Claim 38 (depends on 37)

The method of claim 37, wherein the pharmaceutical grade lipid comprises a fully-hydrogenated soybean oil.

### Claim at position 24

39-45. (canceled)

### Claim 46 (depends on 34)

The method of claim 34, wherein the lipid comprises monoglycerides, diglycerides, and triglycerides.

### Claim 47 (depends on 34)

The method of claim 34, wherein the lipid comprises a hydrogenated lipid, a partially saturated lipid, or a combination thereof.

### Claim 48 (depends on 34)

The method of claim 34, wherein the lipid comprises a soy lipid.

### Claim 49 (depends on 48)

The method of claim 48, wherein the soy lipid comprises a hydrogenated soy lipid.

### Claim at position 29

50-53. (canceled)

### Claim 54 (depends on 4)

The method of claim 4, wherein the pharmaceutical composition is administered to the subject orally.

### Claim at position 31

55-59. (canceled)

### Claim 60 (depends on 4)

The method of claim 4, wherein
the subject is administered one or more doses of the pharmaceutical composition.

### Claim 61 (depends on 60)

The method of claim 60, wherein a dose of the pharmaceutical composition comprises from about 100 to about 9,000 mg of the digestive enzymes.

### Claim at position 34

62-94. (canceled)

### Claim 95

A pharmaceutical composition for treatment of an addiction in a subject in need thereof, wherein the pharmaceutical composition comprises encapsulated, coated digestive enzyme particles, wherein the coated digestive enzyme particles comprise (i) a core that comprises digestive enzymes that comprise a protease, an amylase, and a lipase, and (ii) a coating.

### Claim at position 36

96-119. (canceled)

### Claim 120 (depends on 5)

The method of claim 5, wherein a dose of the pharmaceutical composition comprises from about 650,000 U.S.P. units to about 1.5×106 U.S.P. units of the protease.

### Claim 121 (depends on 120)

The method of claim 120, wherein a dose of the pharmaceutical composition comprises from about 650,000 U.S.P. units/unit dose to about 1.5×106 U.S.P. units/unit dose of the protease.

### Claim 122 (depends on 4)

The method of claim 4, wherein the subject to be treated has a blood level of phenylalanine that is two-fold less than 2 mg/dL or 120 micromolar.

### Claim 123 (depends on 4)

The method of claim 4, wherein a dose of the pharmaceutical composition is formulated as a sachet.
