Bunions hurt, and recovery from bunion surgery can take five months, but the Malvern specialty pharmaceutical company Recro Pharma announced they have just taken significant steps toward making this surgery and other medical procedures more comfortable.

The company has just used its non-opioid Dex-IN as it dosed its first patient in a Phase IIb clinical trial of patients undergoing bunionectomy surgery.

The trial is a randomized, multicenter, double-blind, placebo-controlled study to evaluate the drug’s efficacy and safety. Patients will remain under observation for 48 hours and will be followed for seven days.  In all, 150 to 200 subjects will be enrolled in the study.

“This trial is designed to explore Dex-IN in a robust post-operative setting,” said Gerri Henwood, Recro Pharma’s president and chief executive officer. “Positive results from this Phase IIb clinical trial following bunionectomy surgery would represent a significant advancement for this non-opioid alternative for patients experiencing acute pain following surgery. We expect to report top line data from this trial by the end of 2014.”

The company recently announced first quarter positive financials and a successful initial public offering.  Recro Pharma is banking its future on non-opioid therapeutics.

If Dex-IN gains FDA approval, it would be the first and only acute pain drug in its class and could provide an attractive alternative to commonly prescribed opioids for acute pain. The company believes its drugs would avoid many of the side effects associated with commonly prescribed opioids, including addiction, constipation and respiratory distress while maintaining analgesic effect.

“Bunionectomy surgery typically results in intense post-operative pain. In the past, drugs that have demonstrated analgesic effectiveness following bunionectomy surgery have frequently translated that analgesic success in other post-operative procedures that result in moderate to severe, acute pain,” said Dr. Christina Carnegie, Recro Pharma’s consulting senior medical director.

“We believe that success in treating acute pain associated with bunionectomy surgery will support the use of Dex-IN in addressing moderate to severe acute pain associated with a wide range of surgical procedures.”

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