Rescue treatment of post operative nausea and vomiting

12005,042

17/746032

May 17, 2022

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.

ACACIA PHARMA LTD (Cambridge, GB)

Acacia Pharma Ltd. (Cambridge, GB)

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 (D 2) antagonist.

3. The method of claim 1 , wherein the prophylaxis drug is an anti-emetic selected from a 5HT 3 -antagonist, a corticosteroid, an anti-histamine (H1), an anti-cholinergic, a H 2 -antagonist and a NK 1 -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 5HT 3 antagonist, an NK 1 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.

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