QRxPharma receives new U.S. Patent for MoxDuo IR in treatment of acute pain

Apr 15 2011

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the United States Patent and Trademark Office (USPTO) issued the Company a new patent, U.S. Patent #7,923,453, which expires in 2029. This patent covers a proprietary dosing algorithm for converting patients from intravenous opioid administration to orally administered MoxDuo IR, thereby more effectively and safely managing acute pain following surgery.

"Patients often respond differently to opioids; this algorithm facilitates the personalised dosing of MoxDuo IR by the clinician, thereby improving efficacy and safety.  This is the first of several patent applications filed by the Company to be approved which extend global exclusivity of the MoxDuo Dual Opioid^® product line," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.  "The issued patent describes a clinically derived dosing algorithm to be included in the MoxDuo IR product label to help patients and doctors maintain analgesic control of pain while minimising side effects," Holaday added.

MoxDuo is a patented 3:2 ratio fixed dose combination of morphine and oxycodone that is being developed by QRxPharma in three presentations: oral immediate release (MoxDuo IR), intravenous (MoxDuo IV) and controlled release (MoxDuo CR).  These three product candidates are staged to address the $12 billion global market for the treatment of moderate to severe pain. MoxDuo IR targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the U.S.

As the Company's clinical studies consistently demonstrate, MoxDuo effectively treats acute pain while appreciably diminishing the intensity and frequency of moderate to severe opioid-related side effects when compared to frequently prescribed opioids.  To date, the Company has successfully conducted twelve clinical trials, including three pivotal Phase 3 studies.

Based on QRxPharma's recent pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA), the Company believes it is on track to file an NDA in mid-2011 for the use of MoxDuo IR in the management of moderate to severe acute pain.