Acacia Pharma’s anti-nausea drug Barhemsys has stalled again, with the FDA issuing a second complete response letter in less than a year over problems at the plant that makes the drug’s main ingredient.
Barhemsys is aimed at the 30 percent to 40 percent of surgery patients who suffer from nausea after their operations despite being given prophylactic doses of anti-nausea meds.
“We are extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required statement,” said Acacia’s CEO Julian Gilbert. The company still thinks Barhemsys is “approvable” and is “on track to complete the qualification of an alternative supplier.”
The company is eager “to engage with FDA as soon as possible to determine the most rapid route to obtaining approval for Barhemsys, ” Gilbert said.