# US 2024/0197656 A1 · Bupropion and dextromethorphan for treating nicotine addiction

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- Number: US 2024/0197656 A1
- Document ID: US20240197656A1
- Status: Published application
- Kind: A1
- Application number: 18/590,435
- Filed: 2024-02-28
- Published: 2024-06-20
- Earliest claimed: 2019-01-07
- Assignees: Antecip Bioventures II LLC
- Applicants: Antecip Bioventures II LLC
- Inventors: Herriot Tabuteau
- Web page: https://patentgrep.com/patent/US20240197656A1

## CPC

- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/439: the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46)
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/24: Antidepressants
- A61P 25/34: Tobacco-abuse
- 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

Disclosed herein are methods of treating neurological or psychiatric diseases or disorders, such as nicotine addiction, using a combination of bupropion and dextromethorphan. Related compositions and dosage forms are also described.

## Claims

### Claim 1

A method of treating nicotine addiction, comprising administering a combination once daily to a human being in need thereof, wherein the combination comprises about 90 mg to about 100 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the dextromethorphan free base, and about 175 mg of the bupropion free base, or a molar equivalent amount of a salt form of bupropion.

### Claim 2 (depends on 1)

The method of claim 1, wherein the combination is formulated in a composition that provides sustained release of both dextromethorphan and bupropion.

### Claim 3 (depends on 2)

The method of claim 2, wherein the nicotine addiction is associated with smoking tobacco.

### Claim 4 (depends on 2)

The method of claim 2, wherein the combination comprises about 70 mg of the dextromethorphan free base.

### Claim 5 (depends on 2)

The method of claim 2, wherein the bupropion salt is bupropion hydrochloride.

### Claim 6 (depends on 5)

The method of claim 5, wherein the combination comprises 201.6 mg of bupropion hydrochloride.

### Claim 7 (depends on 2)

The method of claim 2, wherein the combination is administered once daily for at least 21 consecutive days to the human being.

### Claim 8 (depends on 2)

The method of claim 2, wherein the combination is administered once daily for at least 6 weeks to the human being.

### Claim 9 (depends on 2)

The method of claim 2, wherein the human being is an adult.

### Claim 10 (depends on 2)

The method of claim 2, wherein the combination is in a tablet when administered to the human being.

### Claim 11 (depends on 10)

The method of claim 10, wherein the combination is orally administered.

### Claim 12 (depends on 2)

The method of claim 2, wherein the combination is orally administered.

### Claim 13 (depends on 2)

The method of claim 2, wherein the combination is in a tablet further comprising microcrystalline cellulose.

### Claim 14 (depends on 2)

The method of claim 2, wherein the combination is in a tablet further comprising magnesium stearate.

### Claim 15 (depends on 3)

The method of claim 3, wherein administration of the combination of the bupropion and the dextromethorphan results in at least 20% greater reduction in an intensity of nicotine self-administration as compared to bupropion alone as measured by the reduction in the average number of cigarettes smoked per day.

### Claim 16 (depends on 3)

The method of claim 3, wherein administration of the combination of the bupropion and the dextromethorphan results in at least 10% greater reduction in expired carbon monoxide levels as compared to the bupropion alone.

### Claim 17 (depends on 2)

The method of claim 2, wherein the method is more effective than administering the bupropion alone with the same dose regime.