Recro's Late-Stage IV Meloxicam Trial Results Rocket Stock Skyward

The Compound

Meloxicam is long-acting preferential COX-2 inhibitor, possessing anti-inflammatory, analgesic and antipyretic activities believed to be related to the inhibition of cyclooxygenase and subsequent reduction in prostaglandin biosynthesis. An oral form of this therapy has been marketed by Boehringer Ingelheim since 2015. The compound was acquired by Recro from Alkermes Plc ALKS in April 2015.

Primary Endpoint Met

The company clarified that the treatment achieved the primary end point of a statistically significant difference in summed pain intensity difference over the first 24 hours compared to placebo in patients following abdominoplasty surgery.

With this, the company noted that the efficacy program for then IV meloxicam NDA is complete.

The Trial

The Phase III trial evaluated 219 patients for whom a regimen of IV meloxicam or placebo were administered in a 1:1 ratio once in every 24 hours in a multi-center, randomized double-blinded trial. The company also said the study achieved statistical significance for 10 of the secondary endpoints.

Safety Profile Encouraging

According to the company, IV meloxicam was well tolerated, with no difference in serious adverse events related to bleeding for the therapy compared to the placebo.

Way Forward

Recro said it intends to submit additional data from this Phase III trials for presentation at a future scientific conference or in a journal publication.

Roth Capital had said earlier that positive trial results would increase the probability of meloxicam approval to 75 percent from 50 percent. This, according to the firm, would boost its price target of $24 by $5–$7.

At last check, Recro Pharma was rallying 21.78 percent to $9.45 on roughly 25 times its average volume.