Recro Pharma doses first patient in Phase II trial of Dex-IN to treat acute pain

Bunionectomy surgery involves an incision in the top or side of the big toe joint and the removal or realignment of soft tissue and bone.

Around 200-250 patients are expected to be enrolled in the randomized, multicenter, double-blind, placebo-controlled Phase II trial, which will evaluate the efficacy and safety of Dex-IN.

The company said that eligible patients will be randomized to either a 50ug dose of Dex-IN or a placebo intranasal dose given every six hours and will be under observation for 48 hours at study centers.

Patients will be followed for seven days after the initial dose of study medication and there will be an oral opioid rescue treatment available to patients in either treatment group, if required, to provide adequate pain relief.

Recro Pharma president and chief executive officer Gerri Henwood said: "The Day 1 post-operative setting is one where pain is generally stable or declining, while still having significant pain levels present, and provides a valuable intervention point for the reduction or elimination of opioids.

"Unlike therapeutic pain intervention at Day 0 when pain intensity is rapidly escalating, the Company believes pain management with Dex-IN on Day 1 will be more effective based upon input from the company’s advisors and results of its previous Phase II trial.

"We expect to report top line data from this trial by mid-year 2015, and an interim analysis for sample size adjustment is planned when approximately half of the evaluable patients have been enrolled."

The trial’s primary efficacy endpoint is the summed pain intensity difference over 48 hours, SPID48, starting on Post Op Day 1, while additional efficacy endpoints include use of opioid rescue medication and opioid related side effects, and patient global assessment (PGA) of pain control.