A group of experts organized by the FDA has voted 6 to 4 against a move by Pacira Pharmaceuticals to get an approval to use its pain drug Exparel as a regional pain blocker, expanding on its approved use as a local anesthetic. And now the biotech may have to mount some new studies if it plans to pursue this much further.
In a novel use of language, the company noted in a statement that the advisory group “did not reach a unanimous decision on the efficacy and safety of the use of Exparel.”
Pacira’s stock $PCRX dropped 14% in after-market trading.
The vote against Pacira will likely set up a formal rejection by the April PDUFA date, but the agency is not required to follow its experts’ advice.
“We expect Pacira will have to conduct studies in multiple anatomical sites to gain approval for use as a regional nerve block,” said Janney analyst Ken Trbovich, according to a report in Investor’s Business Daily. And they will likely need to design them fundamentally differently from what they pitched the FDA.
“If you are going to talk about opiate-sparing, you are not going to want to compare that to the placebo,” Gregory Terman, a professor at the University of Washington, said during the discussion, according to a report from Healio. “I am not sure too many people would think placebo causes a lot of opiate-sparing. There you really do need an active comparator and the fact that, despite recommendations for active comparators, that has not been what the sponsor has done except with investigator-initiated studies. I am not sure that opioid-sparring was the plan at all.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.Free Subscription