Market Spotlight: QRxPharma on the up

QRxPharma is another step closer to bringing its immediate release dual-opioid pain therapy, MoxDuoIR, to the market with the completion of one of two pivotal Phase III clinical trials held in the United States.

MoxDuo is a compound of two existing drugs, morphine and oxycodone, and QRxPharma hopes to reinforce prior trial findings that it maintains high efficacy in pain relief with fewer side effects, such as nausea and constipation, than either of the two components drugs taken singularly.

This trial included 522 patients experiencing moderate to severe pain following bunionectomy surgery at six US clinics and saw a high completion rate of 94 per cent. According to QRxPharma, this high completion rate is evidence that MoxDuo is better tolerated than the individual opioids that constitute it.

The patients in the trial were given MoxDuoIR consisting of 12 mg of morphine and 8 mg of oxycodone and were compared with other patients that received either 12 mg of morphine or 8 mg of oxycodone alone.

The discontinuation rate (4.7 per cent) due to adverse side effects compared with morphine (2.3 per cent) and oxycodone (4.0 per cent) alone, suggesting MoxDuo has an improved safety and side-effect profile compared to the singular opioid treatments.

"The path to commercialisation is clear," said QRxPharma Managing Director and Chief Executive Officer, Dr John Holaday, in a statement.

"With the successful completion of this pivotal trial, we believe we have satisfied the FDA’s 'combination rule' requirement and clearly demonstrated the efficacy superiority of MoxDuoIR compared to its individual components.”

“We now shift our focus to the final MoxDuoIR registration trial, a study to evaluate the effectiveness of MoxDuoIR in patients following total knee replacement surgery which is projected to complete dosing in Q3 2010.

"Based on earlier pilot study data, we are confident the second pivotal trial will also yield statistically significant results, enabling the Company to file its NDA in Q4 2010.”

QRxPharma's (ASX:QRX) stock price took a 10% jump on the back of the news in morning trading, at 97c as of 11am.