Recro Pharma’s stock value plummeted more than 34 p.c to $6.41 per share Monday, the primary day of buying and selling after the Meals and Drug Administration’s rejection of the Malvern pharmaceutical firm’s new drug software for non-opioid ache drugs.
On Friday, the FDA voted in opposition to granting advertising and marketing approval to Recro for its intravenous meloxicam drug to managed reasonable-to-extreme ache. The FDA initially rejected the corporate’s new drug utility for the medication final 12 months. Recro (NASDAQ: REPH) resubmitted its software in September with data it believed addressed the federal company’s issues.
The FDA, in its full response letter to Recro, stated the delayed onset of IV meloxicam failed to satisfy the prescriber expectations for intravenous medicine. The letter, in accordance with Recro, additionally cited regulatory considerations concerning the function of IV meloxicam as a monotherapy in acute ache, in addition to how it will meet affected person and prescriber wants in acute care settings.
Recro disputed the company’s findings. “We’re extraordinarily dissatisfied with the receipt of a second CRL from the FDA,” stated Gerri Henwood, president, and CEO of Recro Pharma. “We stay steadfast in our perception that IV meloxicam holds vital potential as a remedy choice for reasonable-to-extreme ache in a number of medical settings and stay dedicated to pursuing a path to regulatory approval.
“We’re devoted to bringing this and different non-opioid ache merchandise to the market to assist deal with the crippling opioid epidemic our nation at the moment faces, as we consider they’re a vital instrument for sufferers and physicians to securely and successfully handle ache in a number of scientific settings.”
Henwood mentioned the corporate intends to work intently with the FDA to find out the perfect path ahead to acquire approval for IV meloxicam.
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