QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations
March 29, 2016
QRxPharma's most 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. 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.
This Study is an open-label, single-dose, crossover trial in normal volunteers at one US clinical research site. Study objectives are to: (1) estimate the relative bioavailabilities for each experimental formulation using co-administered sustained release opioids as reference treatments; (2) to select the QRxPharma controlled-release formulation components that best match the PK profile targeted for each compound for incorporation into the MoxDuo?�CR tablet; and (3) facilitate design of pivotal PK studies necessary for developing the final MoxDuo?�CR tablet.
"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," added Holaday.
SOURCE QRxPharma