QRxPharma completes trials of MoxDuo CR

QRxPharma (ASX:QRX) has completed two phase 1 trials of its MoxDuo CR (controlled release) dual-opioid formulation in healthy volunteers.

The two trials were designed to evaluate the rate at which key components of the formulation were absorbed, distributed, metabolised and eliminated by the body.

The first trial, involving 10 subjects, measured the pharmacokinetic profiles of MoxDuo CR tablets to the profiles of the same doses of MS Contin and OxyContin.

MoxDuo CR was found to metabolise according to expectations, and painkiller levels showed little fluctuation.

During the second study in 17 volunteers, it was determined that food consumption does not alter the pharmacokinetic profiles of morphine and oxycodone delivered by the tablets.

The proprietary MoxDuo CR formulation uses a 3:2 ratio of morphine and oxycodone. It is designed to provide at least 12 hours of relief from moderate to severe chronic pain.

MoxDuo includes abuse deterrent and tamper resistant features, and the trial results confirm that the drug's affects were limited when the tablets are crushed or dissolved.

QRxPharma COO Dr. Ed Rudnic said the results of the two trials were encouraging. “Clinical performance of the oral MoxDuo CR formulation clearly exceeded our expectations,” he said.

“When directly compared to OxyContin... MoxDuo CR demonstrated superior bioavailability and sustained blood levels for over 12 hours.”

QRxPharma aims to introduce MoxDuo CR into the US chronic pain market in 2015.

The immediate release variant of the drug, MoxDuo IR, is expected to launch in calender Q3 this year. QRxPharma has partnered with Actavis to commercialise the product in the market.

The company is currently pursuing a New Drug Application for MoxDuo IR with the US FDA, and has been told to expect a decision on approval by around June 25.

QRxPharma (ASX:QRX) shares fell 2.57% in Wednesday's ASX trading to $1.705.