QRxPharma Successfully Completes Phase I Studies

QRxPharma recently announced successful completion of two Phase I studies in healthy volunteers for MoxDuo CR, a controlled-release Dual-Opioid utilizing a 3:2 ratio of morphine and oxycodone. The proprietary MoxDuo CR formulation, encompassing both sustained delivery technology as well as abuse-deterrent and tamper-resistant features, is designed to provide at least 12 hours of analgesia in patients suffering from moderate-to-severe chronic pain, including cancer, lower back, osteoarthritis, and neuropathic pain.

The clinical trials compared blood levels of MoxDuo CR’s components to OxyContin and MS Contin and demonstrated MoxDuo CR’s superior results, with sustained blood levels for up to 24 hours. Further studies indicated MoxDuo CR’s increased resistance to tampering.

“The successful completion of these trials confirms the advantages of this formulation and enables QRxPharma to initiate Phase II proof-of-concept clinical studies mid-year 2012,” said Dr. John Holaday, Managing Director and CEO of QRxPharma. “These data suggest MoxDuo CR may be positioned as a once- or twice-per-day formulation for treating chronic pain, with the potential advantage of significantly reduced side effects as witnessed with immediate-release MoxDuo. In the US alone, the chronic opioid pain market is a $6 billion a year opportunity.”

Two Phase I trials were conducted in healthy volunteers to evaluate the rate at which key components of the MoxDuo controlled-release (CR) formulation were absorbed, distributed, metabolized, and eliminated by the body. The first study compared MoxDuo CR (30 mg morphine SO4/20 mg oxycodone HCl) to the pharmacokinetic profiles of the same doses of MS Contin (30 mg morphine SO4) and OxyContin (20 mg oxycodone HCl) in 10 healthy adult human subjects using a three-way crossover design.

Pharmacokinetic results from the measurement of opioid blood levels over time revealed a MoxDuo CR profile consistent with expectations for a once- to twice-daily formulation.

The second study demonstrated that food consumption does not alter the pharmacokinetic profiles of morphine and oxycodone from MoxDuo CR (30 mg/20 mg) tablets using a two-way crossover design with 17 healthy volunteers. To demonstrate the effects of chronic use on steady-state blood levels, this study also measured the repetitive-dose pharmacokinetic profiles of morphine and its metabolites as well as oxycodone during repetitive (twice daily) administration of MoxDuo CR tablets for 5 days.

The MoxDuo CR tablets used in these clinical tests included QRxPharma’s proprietary Abuse Deterrence Formulation (ADF) technology. As an indication of tamper resistance, attempts to extract morphine or oxycodone by crushing and solubilizing in water or alcohol resulted in very limited (less than 15%) drug recovery. In addition, the ADF technology did not impair human bioavailability of the opioids following oral administration.

“Clinical performance of the oral MoxDuo CR formulation clearly exceeded our expectations. When directly compared to OxyContin, the largest selling opioid for chronic pain, MoxDuo CR demonstrated superior bioavailabilty and sustained blood levels for over 12 hours, especially in the 12- to 24-hour time period. At steady-state, MoxDuo CR provided very low fluctuations of oxycodone. MoxDuo CR appears to be a true once- or twice-a-day delivery system for dual opioids,” said Dr. Ed Rudnic, COO, QRxPharma. “We expect that MoxDuo CR’s sustained blood levels, ADF attributes, and potential side effect benefits will enhance the tolerability and acceptability of MoxDuo CR in the global chronic pain marketplace.”

The CR formulation of MoxDuo encompasses the same 3:2 ratio of morphine and oxycodone as in MoxDuo IR, QRxPharma’s immediate-release acute pain formulation that is scheduled for PDUFA feedback from the US FDA in June 2012. QRxPharma’s US partner for MoxDuo IR, Actavis, Inc., has the option to negotiate for the US license of MoxDuo CR pending achievement of certain MoxDuo IR sales milestones in the acute pain market. MoxDuo CR is expected to launch into the US chronic pain market in 2015.

QRxPharma Limited is a commercial-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management. 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. QRxPharma’s lead product candidate, immediate release MoxDuo, has a Prescription Drug User Fee Act (PDUFA) date of June 25, 2012, when the NDA review by the US FDA will be completed. The company recently signed a strategic partnership agreement with Actavis, Inc. to commercialize MoxDuo IR in the US acute pain market, with product launch anticipated in 3Q, CY2012. QRxPharma may co-promote its products in the US and plans to seek strategic partnerships for worldwide markets. Additionally, the company’s clinical pipeline includes an intravenous (IV) and continuous release (CR) formulations of MoxDuo. For more information, visit www.qrxpharma.com.