Phase III trial of IV Meloxicam showing safety and opioid use data is published in Clinical Pharmacology in Drug Development,-Recro Pharma

Recro Pharma, Inc. announced the publication of clinical data from its Phase III study evaluating the safety of intravenous (IV) meloxicam in patients following major elective surgery. The article, titled �A Phase III, Randomized, Placebo-controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery,� was published online in the medical journal Clinical Pharmacology in Drug Development. A New Drug Application (NDA) for IV meloxicam is currently under review by the FDA and the Company is currently awaiting its assigned PDUFA goal date of March 24, 2019.

The published article describes data from a randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial where IV meloxicam (30mg) or placebo (3:1 randomization) was administered to patients (n=379) who had undergone major elective surgical procedures, including total hip or knee replacements, spinal, gastrointestinal, hernia repair or gynecologic surgeries, among a range of other surgeries. Safety was evaluated via adverse events (AEs), clinical laboratory tests, vital signs, wound healing, and opioid consumption. The incidence of AEs was similar between IV meloxicam and placebo groups (63.0% versus 65.0%). Investigators assessed most AEs as mild or moderate in intensity. AEs of interest (e.g., injection-site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound-healing events) were similar between groups. A greater frequency of serious adverse events (SAEs) occurred in the placebo group (5.5%) versus the IV meloxicam group (2.6%). The most common SAEs were infections (IV meloxicam, n=3 [0.6%]; placebo, n=2 [1.1%]), procedural complications (IV meloxicam, n=6 [1.1%]; placebo, n=3 [1.6%]), and gastrointestinal events (IV meloxicam, n=4 [0.7%]; placebo, n=2 [1.1%]). There were no deaths during the study.

Mean opioid consumption, measured by converting opioid analgesic doses to the IV morphine equivalent dose, was numerically lower in the IV meloxicam group compared with the placebo group at all time points (hours 0-24, 24-48, 48-72, 0-48, and 0-72 hours) and reached statistical significance at hours 0-24, 0-48, and 0-72. Over the treatment period, IV meloxicam was associated with a 23.6% reduction in total opioid use compared to the placebo group. The total IV morphine equivalent dose was 9.2mg lower among IV meloxicam-treated patients, compared to placebo-treated patients, although the difference was not statistically significant (29.8mg versus 39.0mg; p=0.0531)..

See- " A Phase 3, Randomized, Placebo?Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major SurgerySergio D. Bergese Timothy I. Melson Keith A. Candiotti Sabry S. Ayad Randall J. Mack Stewart W. McCallum Wei Du Alexis Gomez Jorge E. Marcet .First published: 20 February 2019 https://doi.org/10.1002/cpdd.666 .