Recro Pharma tees up an NDA for its COX-2 pain drug following positive PhIII program
After taking a look at safety and tolerability in the 722-patient study, the company says it has put the last piece in place for the data puzzle being presented to the FDA for marketing approval of the non-opioid COX-2 inhibitor.
Recro has been positioning its lead therapy for the post-operative market, looking to break in with a therapy that can avoid the perils associated with opioid use. An NDA should arrive at the FDA in early Q3, company execs say.
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