FDA Declines Recro's IV Meloxicam Application
Recro Pharma Inc (NASDAQ: REPH) needs an analgesic of its own.
The firm announced Thursday morning that the U.S. Food and Drug Administration declined to approve its IV meloxicam application for non-opioid pain relief "in its current form."
The Complete Response Letter acknowledged statistically significant outcomes for the primary endpoints but said analgesic effects did not meet FDA expectations and raised questions related to chemistry, manufacturing and controls data.
Why It’s Important
Shares fell 52 percent on the news; IV meloxicam was meant to be Recro’s first marketed product. Management had already begun adding staff to prepare for third-quarter commercialization.
Its next most advanced candidates are in Phase 2 studies.
Notably, though, the company generates about $72 million through its contract development and manufacturing organization.
What’s Next
Despite the roadblock, Recro is not prepared to abandon IV meloxicam just yet.
"We stand behind the body of evidence included in our NDA and are committed to further discussions with FDA in order to bring this important medicine to patients," Recro CEO Gerri Henwood said in a press release. “We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and look forward to working with the agency to find solutions that can contribute to solving the current opioid public health care problem.”
Related Links:
25 Stocks Moving In Thursday's Pre-Market Session
Recro Pharma CEO Talks Non-Opioid Pain Management Opportunity, CDMO Business
See more from Benzinga
© 2018 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
