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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/09/01 | Early Phase 1 | UNKNOWN | |||
2020/06/24 | Phase 4 | UNKNOWN | |||
2020/04/10 | Not Applicable | Recruiting | |||
2019/10/16 | Early Phase 1 | Completed | |||
2019/03/05 | Not Applicable | Completed | |||
2019/01/14 | Phase 4 | UNKNOWN | |||
2018/08/31 | Phase 4 | Completed | |||
2018/07/11 | Phase 1 | Completed | |||
2016/01/05 | Phase 3 | Completed | |||
2015/09/23 | Not Applicable | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AMISULPRIDE-WGR 400 mg tablet blister pack | 178897 | Medicine | A | 11/3/2011 | |
| AMISULPRIDE SCP amisulpride 200 mg uncoated tablet blister pack | 234699 | Medicine | A | 1/29/2016 | |
| APO-Amisulpride 100 mg tablet blister pack | 178904 | Medicine | A | 11/3/2011 | |
| APO-Amisulpride 50 mg tablet blister pack | 178900 | Medicine | A | 11/3/2011 | |
| AMISULPRIDE SANDOZ PHARMA amisulpride 200 mg uncoated tablet blister pack | 234704 | Medicine | A | 1/29/2016 | |
| AMISULPRIDE SANDOZ PHARMA amisulpride 100 mg uncoated tablet blister pack | 234708 | Medicine | A | 1/29/2016 | |
| AMISULPRIDE-WGR 200 mg tablet blister pack | 178905 | Medicine | A | 11/3/2011 | |
| SULPRIX amisulpride 200 mg tablets blister pack | 156048 | Medicine | A | 11/26/2009 | |
| SULPRIX amisulpride 50 mg tablets blister pack | 156047 | Medicine | A | 11/26/2009 | |
| SOLIAN amisulpride 100mg/mL oral solution bottle | 94484 | Medicine | A | 2/12/2004 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AMISULPRIDA TEVA-RATIOPHARM 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 69904 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMISULPRIDA TARBIS 100 mg COMPRIMIDOS EFG | Tarbis Farma S.L. | 67645 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMISULPRIDA TARBIS 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 67647 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMISULPRIDA ARAFARMA GROUP 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Arafarma Group S.A. | 67785 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| SOLIAN 100 mg COMPRIMIDOS | Sanofi Aventis S.A. | 63994 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMISULPRIDA APOTEX 400 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Apotex Europe B.V. | 72568 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMISULPRIDA NORMON 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 69797 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMISULPRIDA NORMON 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 69796 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AMISULPRIDA TARBIS 200 mg COMPRIMIDOS EFG | Tarbis Farma S.L. | 67646 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AMISULPRIDA AUROVITAS 200 MG COMPRIMIDOS EFG | Aurovitas Spain, S.A.U. | 82058 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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