Barhemsys (intravenous amisulpride) / Eagle Pharma - LARVOL DELTA

Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (clinicaltrials.gov) - P2/3 | N=453 | Completed | Sponsor: Acacia Pharma Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Pediatrics

A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Benaroya Research Institute | Not yet recruiting ➔ Recruiting

Bariatric surgery • Enrollment open • Surgery

A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Benaroya Research Institute

Bariatric surgery • New P3 trial • Surgery

Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (clinicaltrials.gov) - P2/3 | N=410 | Recruiting | Sponsor: Acacia Pharma Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Enrollment open • Trial completion date • Trial primary completion date • Pediatrics

Effectiveness of Amisulpride in Preventing Postoperative Nausea and Vomiting after Sleeve Gastrectomy: A Pilot Medical Use Evaluation (ACS-CLINCON 2023) - "Intravenous amisulpride was shown to be safe and effective as prophylaxis for PONV in patients who underwent sleeve gastrectomy when used alone or in combination with another antiemetic."

Gastrointestinal Disorder

A Study of Intravenous (IV) Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (clinicaltrials.gov) - P2/3 | N=410 | Not yet recruiting | Sponsor: Acacia Pharma Ltd | Initiation date: Dec 2022 ➔ May 2023

Trial initiation date • Pediatrics

A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV. (clinicaltrials.gov) - P3 | N=516 | Not yet recruiting | Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

New P3 trial

A Study of Intravenous (IV) Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (clinicaltrials.gov) - P2/3 | N=410 | Not yet recruiting | Sponsor: Acacia Pharma Ltd

New P2/3 trial • Pediatrics

Intravenous amisulpride as rescue treatment of postoperative nausea and vomiting in patients undergoing oncologic surgical procedures. (ASCO 2022) - " This subset analysis includes data from a randomized, double-blind, placebo-controlled, multicenter phase III trial of a single 10 mg dose of IV amisulpride as rescue treatment of PONV occurring in patients failing pre/peri-operative prophylaxis, generally with ondansetron and/or dexamethasone (Habib AS, Kranke P, Bergese SD, Chung F, et al. Amisulpride at 10 mg IV is safe and effective as rescue treatment for PONV in cancer patients undergoing surgery and is associated with a marked reduction in PACU length of stay."

Clinical • Anesthesia • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology

PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Acacia Pharma Ltd; Recruiting ➔ Completed

Clinical • Trial completion • Nephrology • Renal Disease

Intravenous amisulpride: A safer and possibly effective anti-emetic for postoperative nausea and vomiting. (PubMed, Indian J Anaesth) - No abstract available

Journal

PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Acacia Pharma Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Nephrology • Renal Disease

PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Acacia Pharma Ltd

New P1 trial • Nephrology • Renal Disease

Amisulpride: A Review in Post-Operative Nausea and Vomiting. (PubMed, Drugs) - "Amisulpride intravenous (IV) injection (Barhemsys; hereafter referred to as IV amisulpride), a selective dopamine receptor antagonist, is approved in the USA as a single IV infusion for the prevention and treatment of post-operative nausea and vomiting (PONV) in adults...When administered as a single IV infusion, amisulpride had a tolerability profile that was generally similar to that of placebo, with no significant safety concerns identified. Thus, IV amisulpride is a useful additional option in the prevention and treatment of PONV in adults, particularly for patients who have failed previous antiemetic prophylaxis and for whom effective treatment options may be limited."

Journal • Review

IV Amisulpride (Barhemsys) for postoperative nausea and vomiting. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting. (PubMed, Ann Pharmacother) - "A PubMed search (1946 to November 2020) using the terms amisulpride and APD421 was conducted...Additional information is needed on its use for chemotherapy-induced nausea and vomiting and in children. Amisulpride is an important new option for the multimodal management of PONV in adults, and it may be the preferred dopamine antagonist because of the more favorable safety profile that results from its unique pharmacological properties."

Journal • Chemotherapy-Induced Nausea and Vomiting • Hypotension • Pain

[VIRTUAL] Clinical safety and efficacy of amisulpride for the prevention of postoperative nausea and vomiting in patients receiving opioid analgesia: data from a phase III trial (ASHP 2020) - "Patients were randomized to receive either intravenous amisulpride (5 mg) or matching placebo at induction of general inhalational anesthesia, in addition to one standard, nondopaminergic antiemetic, most commonly ondansetron or dexamethasone. Intravenous amisulpride was safe and effective as prophylaxis of PONV when given in combination with an antiemetic from another class to adult patients at high risk for developing PONV undergoing elective surgery under general inhalational anesthesia and receiving postoperative opioid analgesics for pain management."

Clinical • P3 data • Anesthesia • Pain

[VIRTUAL] Pharmacokinetics of the selective D2/D3 antagonist intravenous amisulpride for postoperative nausea and vomiting (PONV): Elucidating effects in key neural circuits (ASHP 2020) - "Results of this analysis help support observations from human and animal studies that amisulpride preferentially binds to D2/D3Rs in the limbic system. These findings may have ramifications for CNS safety and efficacy for amisulpride in nausea and emesis. With high affinity and selectivity for both D2/D3Rs and exhibiting marked potency at D3Rs,2 amisulpride possesses unique neurochemical characteristics."

PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

"@FDA_Drug_Info @FDArecalls APD421 Amisulpride is an antiemetic and antipsychotic medication used at lower doses intravenously to prevent and treat postoperative nausea and vomiting; and at higher doses orally and intramuscularly to treat schizophrenia and acute psychotic episodes" (@Koolholio)

CNS Disorders • Psychiatry • Schizophrenia

[VIRTUAL] Intravenous Amisulpride Cardiac Safety When Administered To Surgical Patients For The Prevention Of Postoperative Nausea And Vomiting (ASA 2020) - "Table 1: QTcB Interval: Clinically Significant Findings by Time Point (Pooled Safety Data from PONV Prevention Clinical Trials) CONCLUSIONS A single dose of IV amisulpride was demonstrated to be safe when administered for the prevention of PONV. The TEAE profiles, hematology and clinical chemistry parameters, cardiac adverse events and ECG parameters for amisulpride were similar to placebo across four randomized, placebo-controlled clinical trials."

Clinical • Anesthesia • CNS Disorders • Hematological Disorders • Psychiatry

Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis. (PubMed, Eur J Clin Pharmacol) - "Based on our findings, low-dose, intravenous amisulpride is safe and efficacious for the prevention and treatment of PONV compared to placebo. Further studies are needed to explore the optimal dose and timing."

Journal • Retrospective data • Review

A pharmacological profile of intravenous amisulpride for the treatment of post-operative nausea and vomiting. (PubMed, Expert Rev Clin Pharmacol) - "Both primary and secondary pharmacology are covered, along with clinical pharmacokinetics (distribution, metabolism and excretion). The review of clinical safety and efficacy includes data from four studies in the prevention of PONV, two in the treatment of PONV and two investigating effects on the QT interval of the electrocardiogram in healthy volunteers."

Journal

"Amisulpride .. Barhemsys ... sounds like #GOT ... FDA Approves New Option for Postop Nausea and Vomiting https://t.co/0I1m9FWeav via @medscape" (@traumamd1)

FDA event