FDA rejects Recro's meloxicam NDA for second time

Recro said FDA issued a second complete response letter for its NDA for IV meloxicam (N1539) to manage moderate-to-severe pain.

Recro Pharma Inc. (NASDAQ:REPH) said the agency was concerned with onset and duration of IV meloxicam, noting that the delayed onset fails to meet the prescriber expectations for IV drugs. The company also said the letter cited regulatory concerns about the role of IV meloxicam as a monotherapy in acute pain, as well as how it would meet patient and prescriber needs in that setting, given FDA's interpretation of the clinical data...