Volume at thinly traded micro cap Recro Pharma ($REPH) increased in response to its announcement that it will refile its marketing application for IV meloxicam, a non-opioid, non-addictive NSAID, by the end of the month. The revised NDA will incorporate revised language related to labeling and additional information on extractable and leachable items. If approved IV meloxicam’s addressable market could reach over 3 billion.
In May 2018, Recro received a complete response letter (CRL) for its pain medication candidate meloxicam, with the CRL stating the analgesic effect observed in the ad hoc analysis did not meet FDA expectations. There were also questions regarding the extractable and leachable data. As a result Recro’s stock fell more than 50%, with investors fearing that the FDA may require additional trial data. Recro’s management, however, indicated the agency had not mentioned a comparator trial, and instead believed the FDA just misinterpreted or misunderstood the intended clinical role that IV meloxicam could have.