MoxDuoTreatment for Pain
QRxPharma Issues Statement On Moxduo Advisory Committee Meeting
Sydney, Australia and Bedminster, New Jersey- April 23, 2014 -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today that the United States Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee has voted to recommend against approval of Moxduo, an immediate release Dual Opioid® for the treatment of moderate to severe acute pain.
The Advisory Committee found the Company did not provide sufficient evidence to warrant approval of Moxduo at this time.“
"We are obviously disappointed in the outcome of today’s meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone. This is a necessary therapy for patients with moderate to severe acute pain,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.“ We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new pain management and abuse prevention products. Based on a development strategy that focuses on enhancing the clinical utility of currently approved compounds as well as bringing new products to market, the Company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risks and improved patient outcomes. The Company’s refiled New Drug Application for its lead product candidate immediate release Moxduo® for the treatment of acute pain, is presently under review at the U.S. Food and Drug Administration. QRxPharma has entered into strategic agreements with Actavis Inc., Paladin Labs Inc., Aspen Group and Teva for the commercialisation of immediate release Moxduo in the US, Canada, Australia (including New Zealand and Oceania), South Africa and Israel. The Company’s clinical pipeline includes an intravenous (IV) and controlled release (CR) formulation of Moxduo. QRxPharma is also collaborating with Aesica Formulation Development Limited, for the worldwide promotion of QRxPharma’s proprietary Stealth Beadlets™ abuse deterrence technology.
For more information, visit www.qrxpharma.com.
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about 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 available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake 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 important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company’s proposed products.
Posted: April 2014
- QRxPharma Announces 25 May 2014 as New PDUFA Date for MoxDuo NDA - December 11, 2013
- QRxPharma Refiles MoxDuo New Drug Application with the FDA - November 26, 2013
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA - August 28, 2013
- FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA - March 14, 2013
- QRxPharma Resubmits MoxDuo New Drug Application to the FDA - February 28, 2013
- QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application - January 16, 2013
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA - June 27, 2012
- QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012 - November 11, 2011
- QRxPharma Completes NDA Submission for MoxDuo IR - August 26, 2011
- QRxPharma Announces NDA Filing for MoxDuo IR - July 19, 2011