Total votes: 1

QRxPharma Ltd. 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. The Company’s lead products comprise a patented combination of existing drugs, with a well-defined path to regulatory approval and sales. QRxPharma’s lead drug compound, MoxDuo IR (Q8003IR), began Phase III clinical trials in November 2007 and filed an NDA in 2011. The Company’s preclinical and clinical pipeline includes other technologies in the fields of neurodegenerative disease and venomics.

Lead Product:
An 25 August 2009 ASX release re their lead product MoxDuo™ IR Demonstrated Fewer Side Effects than Percocet® Pain relieving effects of MoxDuo™ IR are doserelated with a better safety profile than Percocet® in patients with postoperative pain following total knee replacement.

MoxDuo™ IR is the first patented analgesic product in the world that consists of two opioid drugs (a fixed ratio of morphine and oxycodone). While many analgesic combination drugs exist that contain opioids with mild pain drugs such as aspirin, ibuprofen or acetaminophen, combination products such as Percocet®, which contains an opioid (oxycodone) combined with acetaminophen (like Tylenol®) have been the subject of recent FDA scrutiny due to their potential for causing significant adverse effects on liver and gastrointestinal function.

To date, more than 400 patients in six clinical trials have received MoxDuo™ IR for different forms of post‐surgical pain (bunionectomy and total knee replacement) and the drug is in Phase III trials.

During the March 2011 quarter the Company meet a major milestone with completion of a pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA) for its MoxDuo Immediate Release formulation, a patented 3:2 ratio fixed dose combination of morphine and oxycodone, for managing moderate to severe acute pain. Clinical trials  conducted to date have consistently demonstrated the benefits of MoxDuo, achieving as good or better pain relief with fewer incidences of moderate to severe side effects compared to current standards of care.

The 2011 scheduled pre-NDA meeting considered QRxPharma’s regulatory strategy, and the FDA provided constructive feedback on specific sections of the planned NDA. The Company is on track to submit a NDA for MoxDuo IR mid-year 2011 once the comprehensive data analysis is complete.

Cash on Hand:
$7.3M at 30th June 2011

Some Key people:
Chairman Peter Farrell (Founder and Chairman of Resmed)
CEO John Holaday

Possible Upcoming Events:
 - posssible approval of its New Drug Application (NDA) to the US Food and Drug Administration (FDA) Q4 2011 or Q1 2012
 -  the Company anticipates launching MoxDuo IR in 2012 into the US$12 billion global market for opioids