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Recro Pharma's phase II study of Dex-...
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Recro Pharma’s phase II study of Dex-IN meets primary endpoint to treat acute pain
Pharma News

Recro Pharma, Inc., a specialty pharmaceutical company developing multiple non-opioid therapeutics to treat acute post operative pain, announced positive efficacy results from the phase II clinical trial of Dex-IN, a proprietary intranasal formulation of dexmedetomidine, for the treatment of acute pain in adult patients undergoing bunionectomy surgery.

Dex-IN met the primary endpoint of the clinical trial in demonstrating significant pain relief compared with placebo over 48 hours. The company plans to meet with the FDA to discuss its phase III plans and determine what, if any, additional information will be required in association with the phase III clinical programme for Dex-IN.

“The positive top line results support the potential of Dex-IN, a non-opioid alternative, to treat acute post operative pain,” said Gerri Henwood, Recro Pharma’s president and chief executive officer. “We look forward to discussing these phase II results with the FDA and progressing into pivotal phase III clinical trials.”

The phase II trial was a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dex-IN in adult patients undergoing bunionectomy surgery, initiating dosing of study medication on postoperative day 1. Patients who met the eligibility criteria were randomized to either a 50µg dose of Dex-IN or a placebo intranasal dose given every 6 hours. Following the beginning of treatment, patients remained under observation for 48 hours at study centres. Patients were followed for 7 days after the initial dose of study medication. There was an oral opioid rescue treatment available to patients in either treatment group, if required, to provide adequate pain relief. A total of 168 patients were randomized and received study medication in the clinical trial, 84 patients in each treatment group. Seven patients discontinued the study early, six for lack of efficacy (three in each treatment group) and one for a serious adverse event of hypotension.

The primary efficacy endpoint of the trial was the summed pain intensity difference over 48 hours, SPID48, starting on postoperative day 1. Additional efficacy endpoints included use of opioid rescue medication, SPIDs over various time intervals, as well as other standard efficacy analyses. The most common adverse events observed in the study were blood pressure decrease, hypotension, nausea (similar incidences to placebo), nasal discomfort and headache. An adverse event of bradycardia was reported in 3 subjects in the Dex-IN treatment group.

Bunionectomy surgery generally involves an incision in the top or side of the big toe joint and the removal or realignment of soft tissue and bone. This is done to relieve pain and restore normal alignment to the joint. Bunionectomy surgery typically results in intense postoperative pain. In the past, drugs that have demonstrated analgesic effectiveness following bunionectomy surgery have frequently translated that analgesic success into other post operative procedures that result in moderate to severe, acute pain.

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