Morphine + oxycodone combo MoxDuo to control severe pain is completing clinical studies: QRxPharma

MoxDuo, a morphine plus oxycodone combination drug to treat severe pain, is currently in late-phase clinical studies, announced QRxPharma Limited.

QRxPharma has started its second pivotal Phase 3 registration trial to evaluate analgesic efficacy and safety of MoxDuoIR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone.

This two-arm study will compare the effectiveness and safety of a flexible MoxDuo(TM)IR dose regimen to a fixed low dose for managing moderate to severe pain in patients who have undergone total knee replacement surgery.

QRxPharma expects to complete dosing in Q3 2010 in preparation for filing a New Drug Application (NDA) with the US Food and Drug Administration in Q4 2010.

MoxDuo IR targets the acute pain market, a $2.5 billion segment of over $7 billion spent annually on prescription opioids in the US.

“In support of our Phase 3 program, clinical trials conducted to date have consistently demonstrated MoxDuo IR achieves as good or better pain relief with fewer incidences of moderate-severe side effects than morphine, oxycodone or Percocet,” stated Dr. John Holaday, managing director and Chief Executive Officer, QRxPharma.

In 2009, an open-label pilot study demonstrated improved analgesia of flexible dose MoxDuo IR (individual doses up to 24mg morphine/16mg oxycodone) compared to fixed, low dose MoxDuo IR (3mg morphine/2mg oxycodone) in patients with moderate to severe pain following total knee replacement surgery.

Based on these results, low dose MoxDuo IR was selected as the control for this pivotal trial.

The MoxDuo study, a randomised, double blind trial, is targeted to enroll 140 patients (70 per study Arm) at 8 US clinical research sites.

Initially, all post-operative patients will receive intravenous patient controlled analgesia (PCA) morphine until the day following knee replacement surgery.

At such time, PCA morphine dosing will be stopped. When pain becomes moderate to severe [based on the 10-point Numerical Pain Rating Scale (NPRS)], patients will then be randomised in equal numbers to receive either a flexible regimen of MoxDuo IR (Arm 1) or the low dose control (Arm 2).

To date, more than 500 patients experiencing pain following different surgical procedures (bunionectomy and total knee replacement) as well as non-surgical patients with chronic pain have received MoxDuo IR.

MoxDuo IR has greater overall tolerability and allows the doctors and patients to achieve as good or better pain relief with substantially fewer incidences of nausea, vomiting, constipation, dizziness, and hypotension, study data showed.

For example, at equal analgesic doses the frequency of moderate to severe adverse events was 50% to 75% lower among patients on MoxDuo IR than those receiving morphine, oxycodone or Percocet (oxycodone plus acetaminophen).

In December, 2009, QRxPharma announced the initiation of its first Pivotal Phase 3 (combination rule) study in bunionectomy patients to demonstrate that MoxDuo IR provides superior analgesia compared to its component doses of morphine and oxycodone.

QRxPharma expects to complete its Phase 3 program in Q3 2010 and file its NDA for MoxDuo IR by the end of year 2010.

QRxPharma is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain management and central nervous system (CNS) disorders.

QRxPharma’s product portfolio includes both late and early stage clinical drug candidates with well-defined paths to regulatory approval and sales.

MoxDuo is QRxPharma’s lead compound. The Company’s preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics.