Claims for Patent: 12,005,042

Summary for Patent: 12,005,042

Title:	Rescue treatment of post operative nausea and vomiting
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.
Inventor(s):	Julian Clive Gilbert, Robert William Gristwood, Gabriel Fox
Assignee:	Acacia Pharma Ltd
Application Number:	US17/746,032
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,005,042
Patent Claims:	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. 2. The method of claim 1, wherein the prophylaxis drug is not a dopamine-2 (D2) antagonist. 3. 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. 4. The method of claim 1, wherein the amisulpride is administered in combination with another anti-emetic, either sequentially or simultaneously. 5. The method of claim 4, wherein the another anti-emetic is a 5HT3 antagonist, an NK1 antagonist or a steroid. 6. The method of claim 5, wherein the another anti-emetic is dexamethasone, ondansetron, granisetron, palonosetron, aprepitant, netupitant or rolapitant. 7. The method of claim 1, wherein the amisulpride is substantially in the form of a racemate. 8. 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. 9. 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. 10. 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. 11. The method of claim 1, wherein the amisulpride is administered by IV infusion over about 1 to 15 minutes. 12. The method of claim 11, wherein the amisulpride is administered by IV infusion over about 1 to 10 minutes. 13. The method of claim 11, wherein the amisulpride is administered by IV infusion over about 1 to 5 minutes. 14. The method of claim 11, wherein the amisulpride is administered by IV infusion over about 1 to 2 minutes. 15. The method of claim 1, wherein the amisulpride is administered at a dose of 10 mg. 16. The method of claim 1, wherein the amisulpride is administered as a single daily dose. 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.