QRxPharma Completes Patient Enrolment of Phase III Comparative Safety Study

QRxPharma Limited recently announced it has completed patient enrolment for Study 022, a Phase III trial comparing the tolerability and safety profile of MoxDuo IR to equi-analgesic doses of either morphine or oxycodone alone. Specifically, the study evaluated the incidence of opioid-related adverse events, including changes in respiratory function, moderate-to-severe nausea, vomiting, and dizziness, in patients with moderate-to-severe postoperative pain following bunionectomy surgery. The trial enrolled 375 patients (n = 125 per treatment group) at 5 US clinical research sites. QRxPharma expects to release top-line data in June.

“This Phase III trial represents a major milestone as it is the first comparison of MoxDuo IR (12 mg/8 mg) to equi-analgesic doses of morphine and oxycodone,” said Dr. John Holaday, Managing Director and CEO, QRxPharma. “With patient enrolment complete, we are optimistic that the pending results will confirm the significant tolerability and safety advantages of MoxDuo IR over these two widely prescribed opioids.”

A prior comparator study in patients experiencing acute postoperative bunionectomy pain demonstrated the potential side effect and safety benefits of MoxDuo IR (6 mg/4 mg) when compared to equi-analgesic doses of morphine (12 mg) or oxycodone (8 mg). Specifically, the occurrence rate of moderate-to-severe adverse events, including nausea, vomiting, and dizziness was reduced by 50% to 75% in MoxDuo IR-treated subjects compared to patients receiving morphine or oxycodone alone at the same 12-mg MED (morphine equivalent dose).

This Phase III study was similarly designed, but compared MoxDuo IR (12 mg/8 mg – 24 mg MED) with equi-analgesic doses of morphine (24 mg) and oxycodone (16 mg). By design, approximately 40% of the enrolled subjects were age 60 years or older, thus providing ample evaluation of the tolerability of the three treatments in this age group.

Trial results will form part of QRxPharma’s European Marketing Authorisation Application (MAA) scheduled for submission in the first quarter of 2012. Study results, when published in medical literature, may, in conjunction with other trial data, be a component of the promotional package following the projected commercial launch of MoxDuo IR in the US in 2012 and in Europe in 2013.

Based on QRxPharma’s recent pre-New Drug Application meeting with the US FDA, the company believes it is on track to file an NDA for MoxDuo IR in mid-2011. MoxDuo is a patented 3:2 ratio fixed dose combination of morphine and oxycodone. Immediate-release MoxDuo targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US.

QRxPharma Limited is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management and CNS disorders. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the company’s product portfolio includes both late- and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The company intends to co-promote its products in the US and seeks strategic partnerships for worldwide markets.