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news.Recro Pharma said an intravenous version (IV) of its meloxicam (N1539) was successful in the first of two pivotal late-stage trials.
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The drug was being assessed to treat acute postoperative pain in patients following bunionectomy surgery.
In the phase III clinical 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.
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), SPID24-48 (p=0.0050), time to first use of rescue medication (p=0.0076), and various 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 severe adverse events or bleeding events in the IV meloxicam-treated patients.
Recro Pharma president and CEO Gerri Henwood said: “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 acute postoperative setting.
“These data underscore IV meloxicam’s clinical utility and its potential to play a meaningful role as the only IV, 24-hour duration product in the physician’s analgesic toolkit for moderate-to-severe pain.”
Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses anti-inflammatory, analgesic, and antipyretic activities, which are thought to be associated to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis.