QRxPharma initiates comparative study for pain therapy

The double-blind, randomized and repeated fixed-dose study compares MoxDuoIR’s efficacy and safety to corresponding doses of oxycodone and morphine in patients experiencing moderate to severe pain following a scheduled surgical procedure (bunionectomy). The study is targeted to enroll 180 patients at six US clinical research sites.

The primary clinical endpoints for this study focus on pain relief and intensity scores of MoxDuoIR versus equivalent doses of morphine and oxycodone alone during the first 24 hours following surgery. Secondary endpoints include efficacy relating to the time to onset of analgesia and global assessment of effect and safety as measured by the incidence and intensity of opioid-related adverse events.

Data collected from this study will also be used to support final Phase III trials required for new drug application submission. The company expects to complete dosing prior to the second quarter of 2009.

Based on the company’s July 2008 FDA meeting, final Phase III studies for MoxDuoIR will include a combination rule trial in patients experiencing post-surgery (bunionectomy) pain. Data collected from the comparative study will be used to select the optimal dose regimen and sample sizes for the combination rule trial. No additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval, the company said.

John Holaday, managing director and CEO of QRxPharma, said: While successful clinical trials to date have shown the potential of MoxDuo to provide equal or better analgesia with a reduction of total opioid dose and improved tolerability, this study is designed to provide direct evidence of enhanced efficacy when compared to equivalent analgesic doses of morphine and oxycodone alone. Our goal is to demonstrate the clinical value and superiority of MoxDuoIR over its individual components in post-surgical acute pain relief.