IP Library Granted Patent US 10,322,106
Granted Patent B2
US 10,322,106 · App. 15/565,479 · Granted Jun 18, 2019

Combinations of amisulpride and another anti-emetic for treating nausea and vomiting

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Quick Facts
Patent No.
US 10,322,106
App. No.
15/565,479
Granted
Jun 18, 2019
Kind
B2
Abstract

A kit comprises at least one non-IV injectable unit dose of amisulpride and at least one dose of an acute-phase anti-emetic, for simultaneous, separate or sequential use in the treatment or prevention of chemotherapy- or radiotherapy-induced nausea and/or vomiting in a subject, wherein the subject is receiving or has received a chemotherapy or radiotherapy treatment regimen, and wherein the dosage regimen comprises the administration of the or each acute-phase anti-emetic on day 1, day 1 being the same day that a chemotherapy or radiotherapy is administered, and the administration of the, or at least one of the, non-IV injectable unit doses of amisulpride on day 2. Also provided is a kit comprising at least one non-IV injectable unit dose of amisulpride and at least one unit dose of IV amisulpride. Further provided is a non-IV injectable formulation of amisulpride, for use in the treatment or prevention of delayed-phase chemotherapy- or radiotherapy-induced nausea and/or vomiting in a subject.

Claims (18)

1. A kit comprising at least one non-IV injectable unit dose of amisulpride and at least one unit dose of an acute-phase anti-emetic, for use in the treatment or prevention of chemotherapy- or radiotherapy-induced nausea and/or vomiting in a subject, wherein the subject is receiving or has received a chemotherapy or radiotherapy, and wherein the, or each of the at least one acute-phase anti-emetic is for use on the same day as the chemotherapy or radiotherapy, and the at least one non-IV injectable unit dose of amisulpride is for use as a delayed-phase anti-emetic on the day following the chemotherapy or radiotherapy.

2. The kit, for use according to claim 1 , wherein the acute-phase anti-emetic comprises amisulpride, ondansetron and/or dexamethasone.

3. The kit, for use according to claim 1 , wherein the kit additionally comprises at least one unit dose of another delayed-phase anti-emetic agent for use on the same day as the at least one non-IV injectable unit dose of amisulpride.

4. The kit, for use according to claim 3 , wherein the another delayed-phase anti-emetic agent is a 5HT 3 antagonist, an NK 1 antagonists or a steroid.

5. A kit comprising at least one non-IV injectable unit dose of amisulpride and at least one unit dose of IV amisulpride.

6. The kit according to claim 5 , comprising a single intravenous unit dose of amisulpride and a plurality of non-IV injectable unit doses of amisulpride.

7. The kit according to claim 5 , additionally comprising at least one unit dose of another anti-emetic agent.

8. The kit according to claim 7 , wherein the another anti-emetic agent is a 5HT 3 antagonist, an NK 1 antagonists or a steroid.

9. A method for the treatment or prevention of chemotherapy- or radiotherapy-induced nausea and/or vomiting, the method comprising:

step a) administering at least one unit dose of an acute-phase anti-emetic to a patient in need thereof, wherein the patient is receiving or has received a chemotherapy or radiotherapy; and

step b) administering an effective amount of at least one non-IV injectable unit dose of amisulpride as a delayed-phase anti-emetic to the patient.

10. The method according to claim 9 , wherein the or each of the at least one unit dose of the acute-phase anti-emetic is to be administered on day 1, day 1 being the same day that the chemotherapy or radiotherapy is administered, and wherein the at least one non-IV injectable unit dose of amisulpride is to be administered on day 2.

11. The method according to claim 9 , wherein the patient is to be administered at least one unit dose of another delayed-phase anti-emetic on the same day as the at least one non-IV injectable unit dose of amisulpride.

12. The method according to claim 11 , wherein the another delayed-phase anti-emetic agent is a 5HT 3 antagonist, an NK 1 antagonist or a steroid.

13. A method for the treatment or prevention of delayed-phase chemotherapy- or radiotherapy-induced nausea and/or vomiting, the method comprising administering an effective amount of a non-IV injectable formulation of amisulpride to a patient in need thereof, wherein at least one unit dose of the non-IV injectable formulation of amisulpride is to be administered as a delayed-phase anti-emetic on day 2, and wherein the patient has received chemotherapy or radiotherapy on day 1.

14. The method according to claim 13 , wherein the patient is receiving or has received an acute-phase anti-emetic on day 1.

15. The method according to claim 13 , further comprising administering at least one unit dose of another delayed-phase anti-emetic on day 2, on days 2 and 3, or on days 2, 3 and 4.

16. The method according to claim 15 , wherein the another delayed-phase anti-emetic is a 5HT 3 antagonist, an NK 1 antagonist or a steroid.

Assignments (5)
SECURITY INTEREST Recorded Apr 27, 2026
From: LXO IRELAND DESIGNATED ACTIVITY COMPANY
To: KROLL TRUSTEE SERVICES LIMITED, AS SECURITY AGENT
Reel/Frame 074483/0163 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 4, 2026
From: ACACIA PHARMA LIMITED; ACACIA PHARMA, INC.; EAGLE PHARMACEUTICALS, INC.
To: LXO IRELAND DESIGNATED ACTIVITY COMPANY; LXO US, INC.
Reel/Frame 073967/0303 →
RELEASE OF SECURITY INTEREST Recorded Apr 1, 2025
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: ACACIA PHARMA LIMITED
Reel/Frame 070698/0351 →
SECURITY INTEREST Recorded Apr 28, 2023
From: ACACIA PHARMA LIMITED
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 063476/0631 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2017
From: GILBERT, JULIAN CLIVE; GRISTWOOD, ROBERT WILLIAM; FOX, GABRIEL
To: ACACIA PHARMA LIMITED
Reel/Frame 044694/0592 →