The Food and Drug Administration (FDA) has issued a second complete response letter (CRL) to Acacia Pharma regarding the New Drug Application (NDA) for Barhemsys (amisulpride injection).
Barhemsys, formerly known as Baremsis, is novel dopamine D2/D3 antagonist being evaluated for the management of post-operative nausea and vomiting (PONV). The CRL is related to continued deficiencies observed at the contract manufacturer of amisulpride, the active ingredient of Barhemsys. This issue was raised previously in October 2018 when the Company received their first CRL from the FDA.
The Company noted in a press statement that the FDA has not raised any concerns regarding clinical or non-clinical data in the NDA. The submission includes data from four phase 3 trials, including positive results from a study evaluating Barhemsys as a rescue treatment for patients who received prior antiemetic prophylaxis.
Commenting on the CRL, Dr Julian Gilbert, CEO of Acacia Pharma said, “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.”
For more information visit acaciapharma.com.