MOUNTAIN VIEW, Calif., Aug. 17 Based on its recent analysis of the opioid pain management market, Frost & Sullivan recognizes QRxPharma Limited with the 2010 North American Frost & Sullivan Award for New Product Innovation of the Year for MoxDuo® immediate-release (IR) (Q8003IR) - the first patented dual opioid for the management of pain that also addresses some major challenges experienced by currently marketed opioids.
Pain is the leading cause of disability in the U.S., costing over a $100 billion annually. Untreated, pain can negatively affect a patient's quality of life and is associated with social, physical, and psychological problems. While the U.S. opioid pain management market is robust, some undesirable intrinsic features of existing opioids challenge patients and doctors trying to achieve pain relief. One challenge is managing the large amount of severe side effects - nausea, vomiting, respiratory depression, somnolence, and constipation - associated with the use of opioid drugs.
QRxPharma's MoxDuo formulations are novel medications that contain the well-respected opioids morphine and oxycodone in a fixed-ratio dosage form. Together, these two opioids have a complementary effect on pain, ultimately allowing patients to achieve pain relief with a decreased total opioid dose and fewer side effects.
"Moderate-severe adverse events are most likely to affect the patient's recovery, as well as result in increased demand for medical management, including use of concomitant drugs, dosage adjustments, and doctor visits," says Frost & Sullivan Research Analyst Katheryn Symank. "MoxDuo's formulation is based on QRxPharma's patent protected Dual-Opioid® Technology that allows morphine and oxycodone to work synergistically resulting in a more potent pain reliever and a 25 to 75 percent decrease in moderate-severe adverse side effects."
Recent public scrutiny over safety concerns of Vicodin® (hydrocodone and acetaminophen) and Percocet® (oxycodone and acetaminophen), the leading opioids for the treatment of acute pain in terms of number of prescriptions, has seen the FDA's Drug Safety and Risk Management Advisory Committee recommend a ban on two combination drugs of this type. The recommendation was due to the large incidents of liver damage and death from high doses of acetaminophen. Moreover, as opioids are associated with tolerance, patients taking these medications over a long period of time typically require higher doses to achieve the same effect.
In contrast, MoxDuo IR is more effective in pain relief and has a more attractive side effect profile than that of competing products. As part of its comprehensive Phase III clinical trial program, QRxPharma compared equianalgesic doses of MoxDuo IR with morphine, oxycodone or Percocet® in patients with moderate to severe pain following bunionectomy surgery and/or total knee replacement surgery. Patients taking MoxDuo IR reported fewer occurrences of hypotension, constipation, vomiting, and moderate to severe nausea than patients receiving equal analgesic doses of these traditional opioids. In a pivotal Phase III clinical trial comparing the safety and efficacy of MoxDuo IR with its individual components, oxycodone and morphine, MoxDuo IR at twice the dose of each its morphine or oxycodone components was found to provide better efficacy.
In addition to MoxDuo IR, QRxPharma is also developing a controlled-release (CR) and an intravenous (IV) formulation of MoxDuo. MoxDuo CR will provide at least 12 hours of pain relief for patients who need around-the-clock pain relief for lower back pain or cancer pain, while MoxDuo IV can be used in hospitals following surgery by means of patient controlled analgesia (PCA). Recently, the company compared MoxDuo IV in pain following hip replacement, and demonstrated superior pain relief and fewer side effects than PCA morphine, the standard of care. Development of these additional formulations of MoxDuo serves to maximize the patient population with moderate to severe pain for whom an opioid analgesic is needed and allows the company to address the $12 billion moderate to severe pain relief market from the hospital to the home.
"With its lead compound MoxDuo IR, QRxPharma has established itself as a major participant in the U.S. opioid pain management market; no other opioid-opioid combination product is marketed anywhere in the world," says Symank. "Moreover, the development of multiple formulations of MoxDuo acts as a positive driver for growth potential and showcases the company's interest in addressing the pain management needs of a variety of patient groups."
In recognition of the company's achievements in innovative new product development, Frost & Sullivan is pleased to present QRxPharma with the 2010 New Product Innovation of the Year Award in the U.S. opioid pain management market. Each year, Frost & Sullivan presents this award to a company that has developed an innovative element in a product by leverage leading-edge technologies. The award recognizes the value added features/benefits of the product and the increased ROI it offers customers, which in turn increases customer acquisition and overall market penetration potential.
Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
About QRxPharma Limited
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapies for pain management and central nervous system (CNS) disorders. Based on a business strategy to expand the clinical utility and commercial value of marketed and/or existing compounds, QRxPharma's product portfolio includes both late and early stage clinical drug candidates with well-defined paths to regulatory approval and sales. The company intends to copromote its products in the US and seek strategic partnerships for worldwide markets. Its preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics.
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