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Barhemsys FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Apr 5, 2020.

FDA Approved: Yes (First approved February 26, 2020)
Brand name: Barhemsys
Generic name: amisulpride
Dosage form: Injection
Company: Acacia Pharma
Treatment for: Nausea/Vomiting, Postoperative

Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV).

  • Barhemsys is used:
    • for the prevention of PONV either alone or in combination with an antiemetic of a different class
    • for the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
  • Barhemsys is administered as an intravenous infusion over 1 to 2 minutes.
  • Barhemsys causes dose- and concentration-dependent prolongation of the QT interval.
    • Patients should contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal (fainting) episode.
    • Barhemsys should be avoided in patients taking droperidol. ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval such as ondansetron.
  • Common side effects:
    • Prevention of PONV: increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension.
    • Treatment of PONV: infusion site pain.

Development Timeline for Barhemsys

DateArticle
Feb 27, 2020Approval FDA Approves Barhemsys (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting
Sep 26, 2019Acacia Pharma Announces New Barhemsys PDUFA Target Date
Jul  8, 2019Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019
May  3, 2019Complete Response Letter from FDA for Barhemsys
Dec  7, 2018New Barhemsys PDUFA Date Confirmed for 5 May 2019
Nov  6, 2018Acacia Pharma Resubmits Barhemsys New Drug Application
Oct  8, 2018FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
Sep 14, 2018Positive Barhemsys Phase 3 Treatment Data Published in Anesthesia & Analgesia
Jan  4, 2018Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting

Further information

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