Malvern based RecroPharma Inc. has moved its new lead pain drug candidate into a second phase-III clinical study, writes Philadelphia Business Journal.

Phase-III, which is usually the final step taken by a company before seeking approval from the FDA for an experimental treatment, saw the first patients dosed in the pivotal phase of evaluating intravenous meloxicam for acute post-operative pain in patients who have undergone bunionectomy surgery.

A bunionectomy surgical procedure generally involves an incision at the top or on the side of the joint of the big toe, which removes the bunion and helps realign the joint and soft tissue to relieve foot pain. RecroPharma, which specializes in the development of non-opioid therapeutics to treat pain, has plans to enroll around 200 patients in its second phase-III study.

Last week the company also started late-stage testing of IV meloxicam as a potential treatment for acute postoperative pain following “mini” abdominoplasty surgery. The procedure involves the surgical removal of excess fat and skin remaining usually after drastic weight loss, and, in majority of cases, restoring weakened or separated muscles from the abdominal area.

“The commencement of this second pivotal Phase III clinical trial marks another key step in the development of IV meloxicam,” said Gerri Henwood, RecroPharma’s President and Chief Executive Officer. “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. 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.”