Recro Pharma has presented the additional results from its Phase II clinical trial of Dex-IN, an intranasal formulation of dexmedetomidine, to treat acute pain in adult patients undergoing bunionectomy surgery.
Bunionectomy surgery involves an incision on the top or side of the big toe joint and the removal or realignment of soft tissue and bone.
Dex-IN previously reached the primary endpoint of the clinical study, showing significant pain relief compared against placebo over 48 hours.
The Phase II trial was a randomised, multicentre, double-blind, and placebo-controlled trial designed to assess the efficacy and safety of the firm's proprietary intranasal formulation of dexmedetomidin Dex-IN in adult patients undergoing bunionectomy surgery.
In the trial, patients have been randomised to either a 50ug dose of Dex-IN or a placebo intranasal dose given every six hours.
The company randomised 168 patients in the trial. In each treatment group 84 patients received medication in the study.
Patients remained under observation for 48 hours at study centres, following the beginning of treatment. They were followed for seven days after the initial dose of study medication.
According to the firm, the primary efficacy endpoint of the trial was the summed pain intensity difference over 48 hours, SPID48, using the last observation carry forward analysis method.
Additional efficacy endpoints comprised use of opioid rescue medication and SPIDs over various time intervals, as well as other standard efficacy analyses.