Recro Pharma Reports Meloxicam Well Tolerated with Statistically Significant Analgesic Effect

Recro Pharma, Inc. REPH, a revenue generating specialty pharmaceutical company developing non-opioid therapeutics for the treatment of pain, today announced positive results from its Phase II clinical trial evaluating intravenous (IV) meloxicam for the treatment of acute pain following bunionectomy surgery. The primary objective of the trial was to evaluate the safety of IV meloxicam when administered as a bolus injection (over 15-30 seconds) and the primary efficacy endpoint was evaluation of Summed Pain Intensity Difference over 48 hours (SPID48) scores and secondary endpoints evaluated additional efficacy parameters and pharmacokinetics. Safety The safety results demonstrated that IV meloxicam was well tolerated with no serious adverse events, bleeding events or injection site reactions. The most common adverse events (AEs) were nausea, headache, dizziness, pruritus and vomiting, and were comparable to the placebo group. There were no discontinuations due to AEs. The majority of treatment emergent AEs (TEAEs) were mild in nature and determined by investigators to be "not related" or "possibly related" to study drug. There were no vital signs changes that necessitated treatment. There were no observed changes in the evaluation of ECGs. No clinically meaningful lab changes were observed in the meloxicam treatment groups. Efficacy The primary efficacy endpoint of the trial was SPID48 (0-48). Secondary efficacy endpoints included use of opioid rescue medication, SPIDs over various time intervals, and patient global assessment (PGA) of pain control. Both the 30mg and 60mg IV meloxicam treatment arms demonstrated statistically significant reductions in pain intensity, as measured by SPID48 (p=0.007 and p=0.0027, respectively) compared to placebo. Although there were observed differences in opioid consumption among the meloxicam dose groups and the placebo group, in general these differences did not meet statistical significance. "These Phase II bunionectomy results demonstrate favorable tolerability of an IV bolus of meloxicam and its statistically significant efficacy in a post-operative orthopedic surgery population," said Gerri Henwood, Recro Pharma's President and Chief Executive Officer. "The results of this trial, together with the previously reported positive Phase II data in patients undergoing hysterectomy, dental extraction, and laparoscopic abdominal surgeries, suggest that once-daily IV meloxicam has robust analgesic potential and this establishes the basis for our planned pivotal Phase III trials which we expect to initiate during the first quarter of 2016." The Phase II trial was a randomized, single-center, double-blind, placebo-controlled study that enrolled a total of 59 patients. Patients who met the eligibility criteria were randomized to receive either IV meloxicam (30mg or 60mg dosage groups) or placebo once daily for two days. Following the beginning of treatment, patients remained under observation for 48 hours at study centers. Patients were followed for 7 days after the initial dose of study medication. There was an oral opioid rescue treatment available to all patients, if required. Bunionectomy surgery generally involves an incision in the top or side of the big toe joint and the removal or realignment of soft tissue and bone. This is done to relieve pain and restore normal alignment to the joint. Bunionectomy surgery typically results in intense post operative pain. In the past, drugs that have demonstrated analgesic effectiveness following bunionectomy surgery have frequently translated that analgesic success into other post operative procedures that result in moderate to severe, acute pain.