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Recro Pharma Reports Positive Top-Line Results from Pivotal Phase III Clinical Trial of IV Meloxicam

Fifteen of Nineteen Secondary Endpoints Also Met

Management to Host Conference Call and Webcast Today at 5:00 PM ET

MALVERN, Pa., July 26, 2016 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings that is currently developing non-opioid products for the treatment of serious acute pain, today announced positive results from its Phase III clinical trial evaluating intravenous (IV) meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery. In the trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo.

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 201 patients were enrolled and randomly assigned to receive a postoperative regimen of IV meloxicam (30mg bolus injection over 15-30 seconds) or placebo in a 1:1 ratio, once every 24 hours for up to 3 doses following bunionectomy surgery, a representative hard tissue surgery. The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID48 (p=0.0034) compared to the placebo arm. The study also achieved 15 of the 19 secondary endpoints, including statistically significant differences in SPID6 (p=0.0153), SPID12 (p=0.0053), SPID24 (p=0.0084), SPID24-28 (p=0.0050), time to first use of rescue medication (p=0.0076), and several other rescue use and pain relief metrics during the first 48 hours, compared to placebo.

The safety results demonstrated that IV meloxicam was well tolerated with no serious adverse events or bleeding events in the IV meloxicam-treated patients. The most common (≥3%) adverse events (AEs) were nausea, headache, pruritus, constipation, vomiting, dizziness, flushing and somnolence, and were comparable to the placebo group. The IV meloxicam-treated patients experienced injection site pain and injection site erythema at a rate comparable to placebo. The majority of treatment emergent AEs (TEAEs) were mild in nature and there were no discontinuations due to AEs. There were no meaningful differences between treatment groups in vital signs, ECGs or clinical lab assessments.

“The data from this trial demonstrated that IV meloxicam provided rapid and sustained pain relief following bunionectomy surgery, a favorable safety and tolerability profile, and a statistically significant increase in time to opioid rescue medication,” said Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research, and lead investigator of the study. “There are limited non-opioid pain relief options for postoperative patients suffering from moderate-to-severe pain, and these data support that, if approved, IV meloxicam has the potential to provide an important new non-opioid analgesic option for physicians and patients.”

“The exciting data from this pivotal clinical trial continues to build upon the previously demonstrated success of the Phase II program for IV meloxicam in the...


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