�QRxPharma Limited (ASX: QRX; OTCQX: QRXPY), a clinical-stage specialty
pharmaceutical company focussed on the development and commercialization of
therapies for pain and central flighty system (CNS) disorders, proclaimed
today that the U.S. Food and Drug Administration (FDA) recognized its
proposed Phase 3 protocol designs and statistical analyses to demonstrate
the efficacy and safety of Q8003IR, an immediate tone ending dual-opioid
(morphia plus oxycodone) product intended for the management of moderate
to severe acute pain. Pending incorporation of the FDA's recommended
modifications, only deuce Phase 3 trials will be compulsory for NDA filing.
Under this streamlined clinical evolution program, no additional
pharmacological medicine, toxicology or long-term clinical safety studies will be
required for regulatory submission and marketplace approval.
"This is a significant and positive outcome," said Dr. John Holaday,
Managing Director and Chief Executive Officer, QRxPharma, commenting on the
FDA review article meeting. "Acceptance of QRxPharma's streamlined development plan
for Q8003IR is a measuring of success in footing of rock-bottom risk, resource
efficiencies, and potential value of dual opioids. We believe this outcome
serves to reinforce the firmness of our business strategy - to expand the
clinical utility of existing compounds and deliver unexampled treatments for
targeted indications with chiseled paths to regulatory commendation and
gross revenue."
Following QRxPharma's FDA confluence on July 21, 2008, the Company
reported the Agency had determined no new beast safety studies were
required, accepted the design of the proposed combination rule study with
minimal modifications, and launch the proposed number of patients receiving
Q8003IR, as well as the duration of dosing, sufficient for regulatory
submission of a 505(b)2 NDA.
"No extra clinical studies or measures of base hit and efficaciousness
beyond those proposed by QRxPharma were requested," aforementioned Dr. Warren Stern,
Executive Vice President, Drug Development, QRxPharma. "Having successfully
completed an initial Phase 3 trial in April2008, QRxPharma continues to
satisfy FDA requirements and demonstrate the potential of Q8003IR to
provide be or better analgesia with a diminution of total opioid lucy in the sky with diamonds and
improved tolerability."
Final Phase 3 studies for Q8003IR will include a combination principle study
in patients experiencing post-surgery (bunionectomy) pain and placebo
controlled study in patients following total human knee replacement.
Forward Looking Statements This press release contains advanced statements. Forward-looking
statements are statements that are non historical facts; they admit
statements most our beliefs and expectations. Any assertion in this
release that states our intentions, beliefs, expectations or predictions
(and the assumptions underlying them) is a forward-looking statement. These
statements are based on plans, estimates and projections as they ar
currently usable to the management of QRxPharma. Forward-looking
statements thence speak only as of the engagement they are made, and we
set about no obligation to update publicly any of them in light of new
information or future events.
By their very nature, forward-looking statements involve risks and
uncertainties. A number of crucial factors could therefore reason actual
results to differ materially from those contained in whatever forward-looking
statement. Such factors include risks relating to the stagecoach of products
under development; uncertainties relating to clinical trials; dependency on
third base parties; future capital necessarily; and risks relating to the
commercialization of the Company's proposed products.
About QRxPharma QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) is a clinical-stage
specialty pharmaceutical company focussed on the development and
commercialization of new treatments for nuisance management and central nervous
system (CNS) disorders. Based on a business strategy to boom the clinical
utility and commercial value of marketed and/or existing compounds, the
Company's mathematical product portfolio includes both late and early stage clinical
drug candidates with clear paths to regulatory approval and sales.
QRxPharma intends to directly commercialize its products in the US and seek
strategic partnerships abroad. QRxPharma's lead compound, Q8003IR,
completed its first Phase 3 clinical tribulation in April 2008, having met all
primary and secondary endpoints. The Company's preclinical and clinical
word of mouth includes other technologies in the william Claude Dukenfield of pain management,
neurodegenerative disease and venomics. For more information:
http://www.QRxPharma.com.
QRxPharma Limited
http://www.QRxPharma.com
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