QRxPharma has completed two Phase 1 studies of MoxDuo controlled-release (CR), a dual-opioid formulation utilising a 3:2 ratio of morphine and oxycodone.
The MoxDuo CR formulation utilises the company’s Abuse Deterrence Formulation (ADF) technology for providing at least 12 hours of analgesia in patients suffering from moderate to severe chronic pain.
The two Phase 1 trials were intended to evaluate the rate at which key components of the MoxDuo CR formulation were absorbed, distributed, metabolised and eliminated by the body.
The first study compared MoxDuo CR (30mg morphine SO4/20mg oxycodone HCl) to the pharmacokinetic profiles of the same doses of MS Contin (30mg morphine SO4) and OxyContin (20 mg oxycodone HCl) in ten healthy adult human subjects using a three-way crossover design.
Using a two-way crossover design, 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.
Both 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.
QRxPharma managing director and CEO John Holaday said the successful completion of these trials confirms the advantages of the formulation and enables the company to initiate Phase 2 Proof-of-Concept clinical studies mid-year 2012.
"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," Holaday added.
QRxPharma chief operating officer Ed Rudnic said when compared to OxyContin, MoxDuo CR demonstrated superior bioavailabilty and sustained blood levels for over 12 hours, especially in the 12-24 hour time period.
"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," Rudnic added.
The company expects to launch MoxDuo CR into the US chronic pain market in 2015.