# US 12,005,042 B2 · Rescue treatment of post operative nausea and vomiting

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- Number: US 12,005,042 B2
- Document ID: US12005042B2
- Status: Granted
- Kind: B2
- Application number: 17/746,032
- Filed: 2022-05-17
- Published: 2023-03-30
- Granted: 2024-06-11
- Earliest claimed: 2017-02-10
- Assignees: Acacia Pharma Limited
- Applicants: Acacia Pharma Ltd
- Inventors: Julian Clive Gilbert; Robert William Gristwood; Gabriel Fox
- Web page: https://patentgrep.com/patent/US12005042B2

## CPC

- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/416: condensed with carbocyclic ring systems, e.g. indazole
- A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- A61K 31/438: The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
- A61K 31/439: the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46)
- A61K 31/473: ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/5377: not condensed and containing further heterocyclic rings, e.g. timolol
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- 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

Amisulpride is useful in the treatment of postoperative nausea and/or vomiting in a patient, wherein the patient has already been administered a prophylaxis drug for postoperative nausea and/or vomiting, and wherein the dose of amisulpride is 7.5 to 15 mg.

## Claims

### Claim 1

A method for treating postoperative nausea and/or vomiting (PONV) in a patient, comprising administering to the patient amisulpride at a dose of 9.5 mg to 10.5 mg, wherein the patient has been administered a non-amisulpride prophylaxis drug prior to surgery, and wherein the amisulpride is administered by IV infusion over a time period of from about 20 seconds up to about 20 minutes.

### Claim 2 (depends on 1)

The method of claim 1, wherein the prophylaxis drug is not a dopamine-2 (D2) antagonist.

### Claim 3 (depends on 1)

The method of claim 1, wherein the prophylaxis drug is an anti-emetic selected from a 5HT3-antagonist, a corticosteroid, an anti-histamine (H1), an anti-cholinergic, a H2-antagonist and a NK1-antagonist.

### Claim 4 (depends on 1)

The method of claim 1, wherein the amisulpride is administered in combination with another anti-emetic, either sequentially or simultaneously.

### Claim 5 (depends on 4)

The method of claim 4, wherein the another anti-emetic is a 5HT3 antagonist, an NK1 antagonist or a steroid.

### Claim 6 (depends on 5)

The method of claim 5, wherein the another anti-emetic is dexamethasone, ondansetron, granisetron, palonosetron, aprepitant, netupitant or rolapitant.

### Claim 7 (depends on 1)

The method of claim 1, wherein the amisulpride is substantially in the form of a racemate.

### Claim 8 (depends on 1)

The method of claim 1, wherein the amisulpride is administered within 1 hour following a first emetic episode and/or following a first nausea episode.

### Claim 9 (depends on 8)

The method of claim 8, wherein the amisulpride is administered within 30 minutes following the first emetic episode and/or following the first nausea episode.

### Claim 10 (depends on 9)

The method of claim 9, wherein the amisulpride is administered within 15 minutes following the first emetic episode and/or following the first nausea episode.

### Claim 11 (depends on 1)

The method of claim 1, wherein the amisulpride is administered by IV infusion over about 1 to 15 minutes.

### Claim 12 (depends on 11)

The method of claim 11, wherein the amisulpride is administered by IV infusion over about 1 to 10 minutes.

### Claim 13 (depends on 11)

The method of claim 11, wherein the amisulpride is administered by IV infusion over about 1 to 5 minutes.

### Claim 14 (depends on 11)

The method of claim 11, wherein the amisulpride is administered by IV infusion over about 1 to 2 minutes.

### Claim 15 (depends on 1)

The method of claim 1, wherein the amisulpride is administered at a dose of 10 mg.

### Claim 16 (depends on 1)

The method of claim 1, wherein the amisulpride is administered as a single daily dose.

### Claim 17

A method for treating postoperative nausea and/or vomiting (PONV) in a patient, comprising administering to the patient racemic amisulpride at a dose of 10 mg, wherein the patient has been administered a non-amisulpride prophylaxis drug prior to surgery, and wherein the racemic amisulpride is administered by IV infusion over a time period of from about 20 seconds up to about 20 minutes.