Amisulpride

Overview

Amisulpride is a benzamide derivative and a dopamine receptor antagonist that selectively works on dopamine D2 and D3 receptors. As an antipsychotic agent, amisulpride alleviates both positive and negative symptoms of schizophrenia, and it exhibits antidepressant properties in patients with psychiatric disorders, dysthymia, and major depression. Amisulpride predominantly works in the limbic system, which explains its relatively lower risk of extrapyramidal adverse effects compared to other atypical antipsychotic agents. Oral tablets of amisulpride is used in European countries as a treatment for acute and chronic schizophrenic disorders, as well as secondary negative symptoms in mental health disorders such as affective disorders, depressive mood, and mental retardation. Amisulpride is also used as an antiemetic agent. In the US, the intravenous formulation of amisulpride is used to treat and prevent postoperative nausea and vomiting in adults, either as monotherapy or in combination with another antiemetic agent of a different drug class. It is marketed under the brand name Barhemsys.

Indication

Intravenous amisulpride is indicated in adults for the prevention of postoperative nausea and vomiting, either alone or in combination with an antiemetic of a different class. It is also indicated for the treatment of postoperative nausea and vomiting in patients who have received anti-emetic prophylaxis with an agent of a different class or have not received prophylaxis. Oral amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, characterized by positive symptoms with delusions, hallucinations, thought disorders, hostility and suspicious behavior; or primarily negative symptoms (deficit syndrome) with blunted affect, emotional and social withdrawal. Amisulpride also controls secondary negative symptoms in productive conditions as well as affective disorders such as depressive mood or retardation.

Associated Conditions

Acute Schizophrenia
Chronic Schizophrenia
Negative Symptoms
Post Operative Nausea and Vomiting (PONV)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population	2024/09/05	NCT06585540	Phase 3	Not yet recruiting	Benaroya Research Institute
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body	2023/10/04	NCT06066112	Phase 1	Recruiting	The Affiliated Hospital of Qingdao University
An Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Amisulpride in Treating Patients With Schizophrenia and Schizoaffective Disorder Who Have Treatment-Resistant Positive Symptoms	2023/07/21	NCT05956600	Not Applicable	Withdrawn	University of California, Los Angeles
A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.	2023/04/21	NCT05822713	Phase 3	Not yet recruiting	Qilu Pharmaceutical (Hainan) Co., Ltd.
A study of intravenous amisulpride as prevention of post-operative nausea and vomiting in children	2025/01/14	2024-518778-15-00	Phase 3	Completed	Acacia Pharma Limited
Effects of a Single Dose of Amisulpride on Functional Brain Changes	2022/04/26	NCT05347199	Phase 1	Completed	Simone Grimm
Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment	2021/07/08	NCT04954365	N/A	Withdrawn	Acacia Pharma Ltd
Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression	2021/05/06	NCT04876521	Phase 4	UNKNOWN	All India Institute of Medical Sciences, Bhubaneswar
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment	2021/04/19	NCT04849650	Phase 1	Completed	Acacia Pharma Ltd
Psychobiological Mechanisms Underlying Chronic Pain	2020/12/19	NCT04674670	Not Applicable	Completed	susanne becker

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Barhemsys	Acacia Pharma Ltd	71390-125	INTRAVENOUS	2.5 mg in 1 mL	1/20/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SOLIAN TABLET 200 mg	DELPHARM DIJON	SIN09773P	TABLET	200 mg	5/16/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
VICK-AMISULPRIDE TAB 400MG	N/A	VICKMANS LABORATORIES LIMITED	N/A	N/A	1/30/2009

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SOLIAN 200 amisulpride 200 mg tablet blister pack	96425	Sanofi-Aventis Australia Pty Ltd	Medicine	A	7/23/2004
AMISULPRIDE-WGR 50 mg tablet blister pack	178893	GM Pharma International Pty Ltd	Medicine	A	11/3/2011
APO-Amisulpride 200 mg tablet blister pack	178902	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/3/2011
SULPRIX amisulpride 100 mg tablets blister pack	156044	Alphapharm Pty Ltd	Medicine	A	11/26/2009
AMISULPRIDE SCP amisulpride 400 mg uncoated tablet blister pack	234698	Southern Cross Pharma Pty Ltd	Medicine	A	1/29/2016
AMISULPRIDE SCP amisulpride 50 mg uncoated tablet blister pack	234712	Southern Cross Pharma Pty Ltd	Medicine	A	1/29/2016
SOLIAN 100 amisulpride 100 mg tablet blister pack	96422	Sanofi-Aventis Australia Pty Ltd	Medicine	A	7/23/2004
AMISULPRIDE SCP amisulpride 100 mg uncoated tablet blister pack	234706	Southern Cross Pharma Pty Ltd	Medicine	A	1/29/2016
SULPRIX amisulpride 400 mg tablets blister pack	152460	Alphapharm Pty Ltd	Medicine	A	6/10/2009
APO-Amisulpride 400 mg tablet blister pack	178898	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/3/2011

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
AMISULPRIDA NORMON 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	69798	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ARACALM 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Arafarma Group S.A.	70526	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
AMISULPRIDA AUROBINDO 100 MG COMPRIMIDOS EFG	Laboratorios Aurobindo S.L.U.	81605	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
AMISULPRIDA AUROVITAS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aurovitas Spain, S.A.U.	82059	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
AMISULPRIDA AUROBINDO 200 MG COMPRIMIDOS EFG	Laboratorios Aurobindo S.L.U.	81607	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
AMISULPRIDA ARAFARMA GROUP 200 mg COMPRIMIDOS EFG	Arafarma Group S.A.	67786	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
SOLIAN 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Sanofi Winthrop Industrie	3400934874802IP	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
AMISULPRIDA ARAFARMA GROUP 100 mg COMPRIMIDOS EFG	Arafarma Group S.A.	67784	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
AMISULPRIDA AUROBINDO 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Aurobindo S.L.U.	81606	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
AMISULPRIDA MYLAN 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Mylan Pharmaceuticals S.L.	79566	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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