The U.S. Food and Drug Administration rejected for the second time Recro Pharma Inc.'s application for approval of its intravenous meloxicam for the management of moderate to severe pain.
The reason for the latest complete response letter from the regulatory agency was the delayed onset of the non-opioid drug, which did not meet expectations for intravenous treatments.
In addition, the FDA expressed concerns about the drug's ability to meet patient and prescriber needs as a single therapy for acute pain.
The Malvern, Penn.-based company had resubmitted its application in September 2018 following a previous complete response letter from the FDA in May that year citing similar concerns.
"We are dedicated to bringing this and other non-opioid pain products to the market to help address the crippling opioid epidemic our country currently faces," Recro President and CEO Gerri Henwood said in a March 22 press release.
Recro said it strongly disagrees with the FDA's interpretation and its views on the clinical utility of the drug in the acute pain setting. It plans to request a meeting with the regulator to continue the regulatory process.