MoxDuo™ IR (Q8003 IR)

MoxDuo™ IR, QRxPharma’s lead drug candidate, is an immediate release dual opioid intended for the acute management of moderate to severe pain, a $2.5 billion dollar market in the US alone.  This patent-protected combination of morphine and oxycodone has been clinically shown to provide synergistic effects on pain relief with a significant reduction of total opioid dose and side effects. 

MoxDuo™ IR, an immediate release formulation combining morphine and oxycodone entered Phase 3 clinical trials in November 2007.  Among all patients receiving MoxDuo™ IR in the initial Phase 3 trial, approximately 50% reported good to excellent global improvement (vs 13% for placebo) and demonstrated a strong dose-response effect (p<0.001) in reducing pain intensity scores [i.e. the sum of pain intensity difference over 48 hours relative to the first dose (SPID48)] and other measures of analgesic effect. MoxDuo™ IR was generally well tolerated, with a low rate of patient withdrawal (2% to 12% depending on dose vs. 2% for placebo).  In addition, there was minimal somnolence (2% to 8%) and changes to respiratory parameters (respiration rate, oxygen saturation) with no incidences of euphoria reported.  Nausea and vomiting (usually mild) were the most common adverse events.  The Company expects to complete clinical testing and submit a New Drug Application (NDA) in 2009.

Press Releases

• Positive Scientific Advice Meetings in Europe MoxDuo®IR 
  26 July 2010
• QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo®IR in Patients with Post-Surgical Pain
  4 May 2010
• QRxPharma Successfully Completes Pivotal Phase 3 Combination Rule Study for MoxDuo®IR in Patients with Post-Surgical Pain  
  14 April 2010
• QRxPharma Initiates Second Pivotal Phase 3 Study of MoxDuo™ IR Dual-Opioid™ for NDA Submission 
  10 February 2010
• QRxPharma Initiates Pivotal Phase 3 Study of MoxDuo™IR For Moderate to Severe Acute Pain 
  30 November 2009
• MoxDuo™ IR Demonstrates Fewer Side Effects than Percocet®  
  26 August 2009
• QRxPharma Successfully Completes Comparative Study for Dual-Opioid™ Pain Therapy 
  20 April 2009
• QRxPharma Initiates Second Comparative Study for MoxDuo™ IR Dual-Opioid™ Pain Therapy
  19 February 2009
• QRxPharma Initiates Comparative Study for MoxDuo™ IR Dual-Opioid™ Pain Therapy
  16 December 2008
• FDA Accepts Streamlined Phase 3 Development Plan for Q8003IR “Dual Opioid” Pain Therapy 
  5 August 2008
• QRxPharma Releases Additional Phase 3 Data for MoxDuo™ IR ‘Dual Opioid’ Pain Therapy 
  22 May 2008
• QRxPharma Releases Successful Phase 3 Study Results for 'Dual Opioid' Pain Therapy 
  5 May 2008

Posters

• Dual-Opioid Treatment of Acute Postoperative Pain: A Double-Blind, Placebo-Controlled Study
• Efficacy and Safety of Dual-Opioid Treatment With Morphine Plus Oxycodone for Acute Postoperative Pain

Papers

• Dual Opioid™ Therapy (cover)
• Dual Opioid™ Therapy
• Overview of mechanisms Opioid pharmacotherapy: from receptor to bedside