Malvern-based Recro Pharma saw its stock plunge by more than 34 percent after the Food and Drug Administration rejected its new drug application for a non-opioid pain medicine, writes John George for the Philadelphia Business Journal.
The FDA voted on Friday against granting Recro marketing approval for the pharmaceutical company’s intravenous meloxicam drug that manages moderate to severe pain. The FDA already rejected the application last year, but the company resubmitted in September with information it felt addressed the concerns of the agency.
But in a response letter to the company, the FDA said that the delayed onset of IV meloxicam did not meet the prescriber expectations for intravenous drugs. It also cites regulatory concerns over the role of the medicine as a monotherapy for acute pain.
Recro disputes the FDA’s findings.
“We are extremely disappointed with the receipt of a second CRL (Complete Response Letter) from the FDA,” said Gerri Henwood, president and CEO of Recro Pharma.
Now, the company will work closely with the FDA to determine the best way forward.
Read more about Recro Pharma in the Philadelphia Business Journal here.
[uam_ad id=”80503″]
.
[uam_ad id=”80502″]
