Recro Pharma, Inc. (Nasdaq:REPH), a specialty pharmaceutical company with a high-performing revenue generating contract development and manufacturing (CDMO) segment, today announced a moderated poster presentation highlighting new intravenous (IV) meloxicam data at the 44th Annual Regional Anesthesiology and Acute Pain Medicine Meeting, hosted by the American Society of Regional Anesthesia and Pain Medicine, taking place April 11-13, 2019, in Las Vegas.
The abstract was a highly scored submission, and was selected for a five minute oral presentation. In this study, the researchers conducted a network meta-analysis (NMA) assessing the safety and efficacy of IV meloxicam relative to other IV non-opioid analgesics for moderate to severe pain. The analysis was conducted by comparing Recro Pharma’s IV meloxicam data to 17 randomized controlled clinical trials evaluating several non-opioid analgesics, including acetaminophen, ketorolac, placebo combined with a non-opioid and placebo combined with an opioid, across three procedure categories: abdominal, bunionectomy and orthopedic.
A pooled analysis of pain outcomes across all bunionectomy procedure studies and time points demonstrated a probability of 84% that IV meloxicam produced the largest sum of pain intensity difference (SPID). A pooled analysis of pain outcomes across all abdominal procedure studies and time points demonstrated a probability of 72% that IV meloxicam produced the largest SPID. Both of these outcomes are consistent with the Surface Under Cummulative Ranking Curve (SUCRA) rankings. IV meloxicam could not be evaluated against other non-opioid IV analgesics in orthopedic procedures due to a lack of reported pain score data for IV meloxicam in orthopedic procedures. IV meloxicam was associated with a pooled 18% reduction in morphine (milligram equivalent) utilization (range 25% to 12%), compared to a 16% reduction for ketorolac and a 14% reduction for acetaminophen.
For safety, IV meloxicam was associated with lower pooled odds of gastrointestinal opioid-related adverse events (ORADEs) (OR=0.72; 95% credible interval [Crl] 0.66-0.78) and respiratory ORADEs (OR=0.51; 95% Crl 0.42-0.59). IV meloxicam offered no relative benefits with respect to adverse events (AEs) not related to opioids.
“These data show that IV meloxicam is associated with lower pain, morphine utilization and opioid-related AEs postoperatively across a number of important clinical comparisons,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Recro Pharma. “We continue to believe that IV meloxicam would be an attractive non-opioid pain management candidate for the hospital marketplace, and we are committed to working closely with the U.S. Food and Drug Administration to bring it to the physicians and patients who could benefit from it.”
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