QRxPharma Successfully Completes Comparative Phase 1 Proof-of-Concept Study for MoxDuo(R) CR Tablet Formulation
Data Indicates Novel Sustained Release Pharmacokinetic Profile for Controlled-Release Formulation
BEDMINSTER, N.J. and SYDNEY, May 10 /PRNewswire/ -- QRxPharma
announced today the successful outcome of a Phase 1 trial for
MoxDuo CR, a controlled-release (CR) Dual-Opioid(TM) designed to
provide 12 hours of pain relief in patients suffering from moderate
to severe chronic pain (including cancer, lower back,
osteoarthritis and neuropathic). The purpose of the trial was to
determine which of the various experimental formulations provided
the optimum duration of drug levels in the blood.
"The successful outcome of this trial reinforces QRxPharma's
intellectual property that defines MoxDuo CR as a novel,
controlled-release formulation for sustained pain relief. We are
now one step closer to addressing the needs of chronic pain
patients and entering the multi-billion dollar chronic pain
market," said Dr. John Holaday, Managing Director and Chief
Executive Officer, QRxPharma. "QRxPharma remains on track to
finalising the MoxDuo CR tablet by the end of this year and to be
in a position to initiate Phase 2 trials shortly thereafter."
The Phase 1 trial, a single dose crossover design, was conducted
in 14 normal healthy volunteers at one U.S. clinical research site.
This study compared the rate at which key components of the CR
formulation were absorbed, distributed, metabolised and eliminated
by the body to the pharmacokinetic profile of Oxycontin® 20 mg
(sustained release oxycodone).
Pharmacokinetic results are encouraging, and the profile is
consistent with expectations for a twice-daily formulation. Data
from this study will significantly aid QRxPharma and its
manufacturing partner, Patheon Inc., in finalising the target
release profile for the product and finalising the composition of
prototype MoxDuo CR tablets.
The Company's MoxDuo® product portfolio includes both
immediate and controlled release, as well as intravenous
formulations. "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," added Holaday.
CONTACT: Alicia Moran, +1-410-991-7027, for QRxPharma
Posted: May 2010