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news.QrxPharma, a clinical-stage specialty pharmaceutical company, has initiated first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo CR.
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MoxDuo CR contains a fixed 3:2 morphine:oxycodone combination and is intended to be dosed twice daily in patients experiencing chronic pain.
In accordance with the recently approved IND filed with the FDA, the two-part pilot study is expected to compare the rate at which key components of the controlled-release formulation are absorbed, distributed, metabolised and eliminated by the body to the pharmacokinetic profiles of co-administered MS Contin 30mg (sustained release morphine) and Oxycontin 20mg (sustained release oxycodone).
Reportedly, the purpose of the study is to determine which of the various experimental formulations provide the optimum duration of drug levels in the blood for incorporation into MoxDuo CR tablets.
MoxDuo CR is expected to deliver clinical benefits similar to those demonstrated with the company’s immediate release formulation – fewer side effects with equal or better pain relief.
QrxPharma’s advanced product MoxDuo IR, is now in pivotal Phase 3 studies and scheduled for new drug application (NDA) filing with the FDA in Q4 2010.
John Holaday, managing director and CEO at QrxPharma, said: “We are pleased to announce this Phase 1 study as it represents a significant milestone for the company and the advancement of MoxDuo CR to address the multi-billion dollar chronic pain market. With the initiation of this trial, all three MoxDuo product presentations are now in the clinic and progressing toward commercialisation.
“Our goal is to provide physicians and patients with a variety of complementary Dual-Opioids for managing moderate to severe pain from hospital to home. Ultimately, our vision for the MoxDuo CR tablet is to provide 12 hours of relief in patients with moderate to severe chronic pain including cancer, lower back, osteoarthritis, and neuropathic pain. This proprietary formulation, manufactured with Patheon, will not only encompass sustained delivery technology (twice daily dosage), but also abuse deterrent and tamper resistant features.”