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.
“The positive data reported today from this Phase III safety trial demonstrate that the safety profile for IV meloxicam 30mg is in line with prior studies and similar to placebo in acute postoperative pain in patients following a wide range of major soft and hard tissue surgeries,” said Stewart McCallum, Chief Medical Officer for Recro Pharma. “These data are also important because they continue to support the thesis that, if approved, IV meloxicam 30mg has the potential to be a novel, non-opioid alternative for management of patients with moderate to severe pain, such as pain following major surgery.”
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