�QRxPharma Limited (ASX: QRX; OTCQX: QRXPY), a clinical-stage specialty
pharmaceutical company focused on the development and commercialization of
therapies for pain and central queasy system (CNS) disorders, proclaimed
today that the U.S. Food and Drug Administration (FDA) accepted its
proposed Phase 3 protocol designs and statistical analyses to demonstrate
the efficacy and safety of Q8003IR, an immediate freeing dual-opioid
(morphine plus oxycodone) product intended for the management of moderate
to severe acute pain. Pending incorporation of the FDA's recommended
modifications, only 2 Phase 3 trials will be needed for NDA filing.
Under this sleek clinical development program, no additional
pharmacology, toxicology or long-term clinical safety studies will be
required for regulatory submission and food market approval.
"This is a significant and positive resultant," said Dr. John Holaday,
Managing Director and Chief Executive Officer, QRxPharma, commenting on the
FDA reappraisal meeting. "Acceptance of QRxPharma's streamlined development plan
for Q8003IR is a measuring stick of success in terms of reduced risk, resource
efficiencies, and potential value of dual opioids. We believe this outcome
serves to reward the soundness of our business strategy - to expand the
clinical utility of existing compounds and deliver new treatments for
targeted indications with chiseled paths to regulatory commendation and
sales."
Following QRxPharma's FDA confluence on July 21, 2008, the Company
reported the Agency had determined no new creature safety studies were
requisite, accepted the design of the proposed combination formula study with
minimal modifications, and establish the proposed number of patients receiving
Q8003IR, as well as the continuance of dosing, sufficient for regulatory
submission of a 505(b)2 NDA.
"No extra clinical studies or measures of safety and efficacy
beyond those proposed by QRxPharma were requested," said 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 equal or better analgesia with a diminution of summate opioid dosage and
improved tolerability."
Final Phase 3 studies for Q8003IR will include a combination rule study
in patients experiencing post-surgery (bunionectomy) pain and placebo
controlled study in patients following total genu replacement.
Forward Looking Statements
This press release contains innovative statements. Forward-looking
statements are statements that are not historical facts; they include
statements or so our beliefs and expectations. Any statement 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 are
currently useable to the management of QRxPharma. Forward-looking
statements therefore speak only as of the date they are made, and we
take in charge no responsibility to update publicly whatever of them in light of new
information or future events.
By their very nature, forward-looking statements involve risks and
uncertainties. A number of authoritative factors could therefore lawsuit actual
results to differ materially from those contained in whatever forward-looking
statement. Such factors include risks relating to the point of products
under development; uncertainties relating to clinical trials; dependency on
third parties; succeeding capital inevitably; 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 pharmaceutic company focussed on the development and
commercialization of new treatments for painfulness management and central aflutter
system (CNS) disorders. Based on a business strategy to expand the clinical
utility and commercial value of marketed and/or existing compounds, the
Company's product portfolio includes both late and early stage clinical
drug candidates with well-defined paths to regulatory approving and sales.
QRxPharma intends to direct commercialize its products in the US and attempt
strategic partnerships abroad. QRxPharma's lead compound, Q8003IR,
completed its low Phase 3 clinical trial in April 2008, having met all
primary and secondary endpoints. The Company's preclinical and clinical
pipeline includes other technologies in the fields of pain management,
neurodegenerative disease and venomics. For more information:
http://www.QRxPharma.com.
QRxPharma Limited
http://www.QRxPharma.com
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