Recro shares crater after CRL for analgesic

Recro Pharma Inc. (NASDAQ:REPH) lost 55% to $5.63 on May 24 after FDA issued a complete response letter for its NDA for IV meloxicam (N1539) to manage moderate to severe pain.

The CRL said data from ad hoc analyses and some secondary endpoints "suggest the analgesic effect does not meet the expectations of the FDA" and that the NDA is not approvable "in its current form," according to Recro. FDA also raised CMC-related questions about the NDA's data. The cyclooxygenase-2 (COX-2) inhibitor did lead to significant improvements on the primary endpoints in Phase III trials, Recro said...