# US 2021/0330656 A1 · Method of treatment with tradipitant

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- Number: US 2021/0330656 A1
- Document ID: US20210330656A1
- Status: Published application
- Kind: A1
- Application number: 17/370,211
- Filed: 2021-07-08
- Published: 2021-10-28
- Earliest claimed: 2017-11-17
- Assignees: Vanda Pharmaceuticals Inc.
- Applicants: Vanda Pharmaceuticals Inc.
- Inventors: Mihael H. Polymeropoulos; Gunther Birznieks
- Web page: https://patentgrep.com/patent/US20210330656A1

## CPC

- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K 31/444: containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- 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 is a method of treatment of gastric motility disorders and of improving gastric motility comprising treatment with the NK-1 receptor antagonist, tradipitant.

## Claims

### Claim 1

A method of treatment of a patient diagnosed with gastroparesis comprising:
administering to said patient tradipitant, in an amount and at a frequency of administration sufficient to achieve and to maintain a plasma concentration of at least about 175 ng/mL for the duration of the treatment regimen.

### Claim 2 (depends on 1)

The method of claim 1, wherein the tradipitant is orally administered in a solid immediate release form comprising tradipitant and one or more pharmaceutically acceptable excipients.

### Claim 3 (depends on 2)

The method of claim 2, wherein the solid immediate release form is administered twice daily.

### Claim 4 (depends on 1)

The method of claim 1, wherein the tradipitant is orally administered in a solid controlled release form comprising tradipitant and one or more pharmaceutically acceptable excipients.

### Claim 5 (depends on 4)

The method of claim 4, wherein the solid controlled release form is administered once daily.

### Claim 6 (depends on 1)

The method of claim 1, wherein the patient is being treated for at least one symptom selected from the group consisting of: nausea, vomiting, early satiety, postprandial fullness, dyspepsia, functional dyspepsia, bloating, and abdominal pain.

### Claim 7 (depends on 1)

The method of claim 1, further comprising administering to said patient tradipitant, in an amount and at a frequency of administration sufficient to achieve and to maintain a plasma concentration of at least about 200 ng/mL or about 225 ng/mL for the duration of the treatment regimen.

### Claim 8

A method of treating a patient diagnosed with gastroparesis, the method comprising:
orally administering to the patient tradipitant in an amount of 150 to 400 mg/day.

### Claim 9 (depends on 8)

The method of claim 8, further comprising orally administering to the patient tradipitant in a solid controlled release form comprising tradipitant and one or more pharmaceutically acceptable excipients, once daily.

### Claim 10 (depends on 8)

The method of claim 8, further comprising orally administering to the patient tradipitant in a solid immediate release form comprising tradipitant and one or more pharmaceutically acceptable excipients, twice daily.

### Claim 11 (depends on 8)

The method of claim 8, further comprising orally administering to the patient tradipitant in an amount of about 170 mg/day.

### Claim 12 (depends on 11)

The method of claim 11, wherein the amount of about 170 mg/day is about 85 mg BID.

### Claim 13 (depends on 8)

The method of claim 8, wherein the patient is being treated for at least one symptom selected from the group consisting of: nausea, vomiting, early satiety, postprandial fullness, dyspepsia, functional dyspepsia, bloating, and abdominal pain.

### Claim 14

A method of treatment comprising:
administering tradipitant to an individual suffering from gastroparesis, wherein the tradipitant is in an amount sufficient to relieve the at least one symptom of gastroparesis that is about 170 mg/day.

### Claim 15 (depends on 14)

The method of claim 14, wherein the individual suffers from at least one symptom of gastroparesis selected from the group consisting of: delayed gastric emptying, nausea, vomiting, early satiety, postprandial fullness, abdominal pain, and bloating.