FDA Rejects Malvern-Based Recro Pharma’s Application for Non-Opioid Pain Med
Recro Pharma’s stock took a major hit after the FDA rejected a new drug application for the Malvern company’s non-opioid pain medication, writes John George for the Philadelphia Business Journal.
The specialty pharmaceutical company’s stock dropped more than 50 percent.
The FDA said it’s unable to approve the application for IV Meloxicam in its current form. It’s an intravenous formulation of an oral drug already available in tablet form. Recro Pharma was seeking FDA approval for use of the medicine in the management of moderate to severe, post-operative pain.
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In a letter, the FDA acknowledged that late-stage clinical testing results demonstrated “statistically significant outcomes.” But the data suggested that the analgesic effect of the drug does not meet the expectations of the agency.
“We are extremely disappointed for patients and providers who are looking for a non-opioid alternative for relief of pain,” said Gerri Henwood, Recro Pharma’s CEO.
Read more about Recro Pharma in the Philadelphia Business Journal here.
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