Join Free For Buyer|Sign In

Professional Online Trade Platform for API, Preparation and Pharmaceutical Machinery and Equipment_EN-CPhI.cn

You are here:  Home >>  News >>  Research & Development >>  Complete Response Letter from FDA for Barhemsys

Complete Response Letter from FDA for Barhemsys

may 20, 2019 By drugs

Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a second Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Barhemsys (amisulpride injection). The letter identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys.

As previously, no concerns were raised by FDA on any of the clinical or non-clinical data in the NDA and no further studies or data analyses will be required for approval.

“We are extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required standards,” said Dr Julian Gilbert, CEO of Acacia Pharma. “As there were no other issues raised with our application, we remain confident that Barhemsys is approvable. We are on track to complete the qualification of an alternative supplier of amisulpride and plan to engage with FDA as soon as possible to determine the most rapid route to obtaining approval for Barhemsys.”

About Acacia Pharma

Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.

The Group's lead project, Barhemsys for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.

Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

Register as Visitor to CPhI China 2019!

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com.

Readers'Comments
Add a comment
Click here to Login or to Register for free. You will be taken back to your selected item after Login/Registration.
More>> MarketNews
More>> Editors’Picks
More>> TopStories
More>> HotTags
Follow Us
CPhI Online Trade Platform: Worldwide|English|中国站
Customer Service:  86-400 610 1188 (9: 00-18: 00, Mon-Fri)
About Us| Contact Us| Terms of Services| Privacy Policy| Intellectual Property Statement| Links | Site Map
Copyright 2006-20 Shanghai UBM Sinoexpo International Exhibition Co Ltd (All Rights Reserved). ICP 05034851-53
网页对话
live chat