US-based Recro Pharma has started a Phase III clinical trial of intravenous (IV) meloxicam (N1539) to treat acute postoperative pain in patients.
Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses anti-inflammatory, analgesic, and antipyretic activities.
These activites are related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis.
The company aims to develop multiple non-opioid therapeutics for treating pain.
The trial is designed to evaluate IV meloxicam’s management of postoperative pain following bunionectomy surgery, a representative hard tissue surgery.
Around 200 patients will be randomly assigned to a postoperative regimen of IV meloxicam (30mg) or placebo in a 1:1 ratio, once every 24h for up to three doses after surgery.
The trail’s primary endpoint is difference in pain intensity over the first 48h (SPID48) compared to placebo.
Recro Pharma president and chief executive officer Gerri Henwood said: "The commencement of this second pivotal Phase III clinical trial marks another key step in the development of IV meloxicam.
"We now have two ongoing pivotal Phase III trials in both hard and soft tissue models and we expect to report top-line results from both trials by the end of 2016.
"There is a growing interest in the availability and use of non-opioid pain treatments. There are limited non-opioid pain treatment options available for hospitalised patients recovering from surgery with moderate to severe pain.
"With IV meloxicam’s demonstrated efficacy in multiple Phase II trials, favorable tolerability, and a desirable dosing profile, we believe that IV meloxicam has the potential to be a new and differentiated non-opioid treatment option for patients with moderate to severe pain."
Bunionectomy surgery normally involves an incision in the top or side of the big toe joint, as well as the removal or realignment of soft tissue and bone, which typically results in intense postoperative pain.
Recro owns and operates an 87,000ft², DEA-licensed facility, which produces and receives manufacturing revenues for five commercial products.