- Ultra-thinly traded nano cap Recro Pharma (REPH +37%) heads north on a 7x surge in volume, albeit on turnover of only 105K shares, in response to its announcement of positive results from a 201-subject Phase 3 clinical trial assessing intravenous (IV) meloxicam for the treatment of acute postoperative pain in patients following bunionectomy surgery, a painful procedure that requires an incision in the top or side of the big toe joint.
- The study met its primary endpoint of showing a statistically valid reduction in pain intensity over 48 hours compared to placebo (p=0.0034). Participants were randomized 1:1 to receive either a postoperative regimen of IV meloxicam (30 mg bolus injection over 15-30 seconds) or placebo once every 24 hours up to three times.
- IV meloxicam was well tolerated with non serious adverse events or bleeding events reported.
- The company intends to submit additional data from the study for presentation at a future scientific conference or for publication.
- A second Phase 3 evaluating IV meloxicam in abdominoplasty surgery is ongoing. Top-line results should be available in Q4. If all goes well, a New Drug Application (NDA) will be submitted to the FDA in mid-2017.
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Meloxicam is an anti-inflammatory and analgesic agent called a COX-2 inhibitor. It has been marketed since the 1990s in an oral formulation by Boehringer Ingelheim. Recro acquired the rights to the intravenous/intramuscular formulation from Alkermes in April 2015.