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news.Recro Pharma said one of its lead product candidates, intravenous (IV) meloxicam, reduced pain in post-operative orthopedic surgery patients and was safe and well tolerated in a phase II clinical trial.
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The drug had no serious adverse events, bleeding or injection site reactions, the company said.
The 59-patient trail has revealed that patients who were given 30 mg and 60 mg doses of the drug had significant reduction in the intensity of pain compared with those on placebo.
Even though there were observed differences in opioid consumption among the meloxicam dose groups and the placebo group, the differences did not meet statistical significance.
Recro Pharma president and CEO Gerri Henwood said: "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."
The company expects to start phase III trials of the drug in the first quarter.
Meloxicam is a preferential COX-2 inhibitor that has anti-inflammatory, analgesic, and antipyretic activities, which are believed to be associated to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis.
It has been marketed since the 1990s in an oral formulation by Boehringer Ingelheim Pharmaceuticals.
Recro Pharma acquired IV/IM meloxicam from Alkermes in April last year.