Shares of Recro Pharma Inc (NASDAQ:REPH) dove Monday after the pharmaceutical company received a second complete response letter from the Food and Drug Administration about its new drug application for its intravenous drug meloxicam to treat moderate to severe pain.
The FDA’s comments in the letter note that IV meloxicam’s delayed onset fails to meet prescribers’ expectations for intravenous (IV) drugs. Regulators also have concerns over the use of meloxicam as a monotherapy for acute pain.
In response, Recro shares tumbled 33.6% to hit $6.43 in afternoon trade Monday.
The Malvern, Pennsylvania company said it “strongly disagrees” with the FDA’s interpretation and its views on the utility of IV meloxicam to address acute pain.
READ: Oppenheimer says Recro Pharma on track for approval of painkiller as overhang over stock eliminated
“We are extremely disappointed with the receipt of a second CRL from the FDA,” said Gerri Henwood, CEO of Recro Pharma in a statement. “We remain steadfast in our belief that IV meloxicam holds significant potential as a treatment option for moderate to severe pain in multiple clinical settings and remain committed to pursuing a path to regulatory approval.”
Recro will request a meeting with the FDA as it continues to seek the drug's approval.
It received its first complete response letter in response to meloxicam last May. At the time, regulators said that data suggests the non-opioid pain killer’s analgesic effect fails to meet FDA expectations.
Recro Pharma is a specialty pharmaceutical company that operates via two businesses: an Acute Care hospital product division, and a revenue-generating contract development and manufacturing group in Gainesville, Georgia.
Contact Ellen Kelleher at [email protected]
-- This story has been updated to reflect latest stock price change --