Malvern, Pa.-based Recro Pharma Inc. will resubmit a new drug application for its intravenous non-opioid painkiller meloxicam following a type A meeting with the U.S. Food and Drug Administration.
Type A meetings are conducted for stalled drug development programs to address an important safety issue. The July meeting examined the FDA's complete response letter for meloxicam in which the regulator said data from the drug's clinical trials showed an analgesic effect that did not meet expectations. In the letter, FDA also raised concerns regarding the chemistry, manufacturing and controls on extractable and leachable data provided in the application.
The resubmitted application will include revised language for the intravenous drug's product label as well as additional information on the extractable and leachable items, Recro Pharma said in a Sept. 4 release. The company expects to file the new drug application by the end of September.