SYDNEY and BEDMINSTER, N.J., Aug. 31 /PRNewswire/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today it will sponsor a symposium at the 13th World Congress of Pain on 31 August, 2010 at Palais des congres de Montreal. The symposium, titled "Dual Opioid Therapy: Changing the Paradigm" will focus on preclinical and clinical data for MoxDuo®IR, an immediate-release Dual Opioid product for moderate to severe acute pain. Featured speakers who will highlight Dual Opioids at this symposium are internationally recognised pain experts, Drs. Nicholson, Pasternak and Webster.
In addition to the symposium, QRxPharma was invited to present three posters on September 2, from 9:30-10:30 with the results from MoxDuo IR comparative trials:
- "Morphine Equivalent Doses of Dual Opioid Treatment With Morphine Plus Oxycodone Versus Morphine and Oxycodone Monotherapy for Post-Operative Pain: Safety and Analgesic Profiles"
- "Treatment of Post-Operative Pain With a Dual Opioid Combination of Morphine and Oxycodone: Analgesia and Side Effects"
- "An Active Controlled Evaluation of the Efficacy and Safety of Dual Opioid Treatment With Morphine Plus Oxycodone for Acute Pain Following Total Knee Arthroplasty"
In the recently completed Phase 3 Combination Rule Study, MoxDuo IR demonstrated both a statistically superior analgesic effect compared to morphine and oxycodone alone as well as a favourable side effect profile despite delivering twice the opioid dose of its individual components. The Company is currently completing its final Phase 3 registration trial for MoxDuo IR in patients who have undergone total knee replacement surgery.
When compared to other opioids at equi-analgesic doses, MoxDuo IR reduced the occurrence rate and intensity of moderate to severe nausea, vomiting and dizziness by 50-75% or more (study 021) and demonstrated when such Adverse Events (AEs) do occur they are frequently of shorter duration among MoxDuo IR subjects than the controls.
According to a report published in 2006 in The British Journal of Pharmacology(1), the search for an analgesic that combines opioid-like efficacy without the well known adverse event profile associated with these drugs has been likened to that for the "Holy Grail" of pain therapy. The rate of occurrence for nausea, vomiting, dizziness, sedation, and constipation, are estimated to occur in "tens of millions" of Americans suffering from acute and chronic pain every year(2). Incremental costs to the health care system for GI events caused by opioids alone are estimated to range from $4,880 to $36,152 per patient(3).
Therefore, the ability of MoxDuo IR to markedly reduce the occurrence of moderate-severe AEs has important clinical and economic benefits. Having demonstrated reductions of 50%-75% of adverse events, MoxDuo IR opens the therapeutic window for acute pain patients suffering from moderate to severe pain and provides the potential for significant healthcare cost reductions in the treatment of patients receiving opioid therapy.
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management and central nervous system (CNS) disorders. Based on a development strategy which focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company intends to directly commercialise its products in the US and seek strategic partnerships for worldwide markets. QRxPharma's lead product candidate, MoxDuo®IR, is in Phase 3 clinical development and has successfully completed multiple comparative studies evaluating its efficacy and safety against equianalgesic doses of morphine, oxycodone and Percocet® for the treatment of acute pain. Data collected from these studies provided additional guidance for optimizing the design and initiation of two pivotal Phase 3 studies required for New Drug Application (NDA) filings with the US Food and Drug Administration (FDA). QRxPharma expects to complete its Phase 3 program Q4 2010 and file its NDA for MoxDuo®IR by Q1 2011. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information, visit www.qrxpharma.com.
The International Association for the Study of Pain (IASP) is the leading professional forum for science, practice, and education in the field of pain. The biennial World Congress on Pain meeting, is the world's largest pain-related gathering, and is international and multidisciplinary in scope.
(1)75 years of opioid research: the exciting but vain quest for the Holy Grail – Alistair D. Corbett, Graeme Henderson, Alexander T. McKnight and Stewart J. Paterson: British Journal of Pharmacology (2006) 147, S153-162.
(2)Gregorian Jr., RS et al. J Pain (May 2010); (EPub ahead of Print): 1-14
(3)Kwong JW, et al. Ann Pharmacotherapy (2010); 44:630-640