- Results from a Phase 2 clinical trial assessing one of Recro Pharma's (REPH +0.5%) lead product candidates, intravenous (IV) meloxicam, for the treatment of acute pain following bunionectomy surgery showed it to be both safe and effective.
- The primary efficacy endpoint was the difference in pain intensity over 48 hours after surgery versus placebo as measured by a rating scale called Summed Pain Intensity Difference (SPID48). Both the 30 mg dose of IV meloxicam and the 60 mg dose showed statistically significant reductions in post-surgery pain compared to placebo (p=0.007 and p=0.0027, respectively).
- IV meloxicam was well tolerated with no serious adverse events, bleeding events or injection site reactions observed. The most common adverse events were nausea, headache, dizziness, itchy skin and vomiting. There were no treatment discontinuations due to adverse events.
- 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. A Phase 3 study should commence this quarter.
- Bunionectomy surgery is a very painful procedure that requires an incision in the top or side of the big toe joint.
- Previously: Recro Pharma completes acquisition of certain Alkermes assets; Shares rise (April 13, 2015)