Pain relieving effects of MoxDuo(TM) IR are dose-related with a better safety profile than Percocet(R) in patients with post-operative pain following total knee replacement
QRxPharma Limited (ASX: QRX) and (OTCQX: QRXPY) announced today successful completion of its pilot study to evaluate the analgesic efficacy and safety profile of MoxDuo(TM) IR (immediate release) capsules in patients with moderate to severe pain following total knee replacement surgery. When compared at equianalgesic doses with Percocet(R), the second most widely prescribed opioid in the US, MoxDuo(TM) IR demonstrated greater overall tolerability with substantially fewer incidences of moderate to severe nausea, vomiting, constipation, and hypotension than Percocet(R). Scheduled for launch in 2011, MoxDuo(TM) IR targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US.
"This study serves to reinforce earlier clinical findings that showed improved tolerability and again demonstrates the value of our Dual-Opioid platform as MoxDuo IR opens the therapeutic window for treating patients suffering from acute post-surgical pain," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We believe the MoxDuo product portfolio, including immediate release, controlled release and intravenous formulations, will significantly improve patient care, providing equal or better analgesia with fewer and/or less intense side effects than current standards of care."
MoxDuo(TM) 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(R), which contains an opioid (oxycodone) combined with acetaminophen (like Tylenol(R)) 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). Study results with MoxDuo(TM) IR consistently demonstrate fewer side effects than observed with morphine alone, oxycodone alone and now with Percocet(R).
In this open label trial, each group of patients who experienced moderate to severe post-operative pain following total knee replacement surgery were treated every four to six hours over a 48-hour period. The study enrolled a total of 44 patients at five US clinical research sites.
All primary study objectives were met comparing: (1) the analgesic efficacy and safety profile of MoxDuo(TM) IR against control groups of patients receiving Percocet(R), a frequently used opioid for the treatment of pain; and (2) a flexible dosing regimen of MoxDuo(TM) IR against a fixed low dose (3/2mg). Patients receiving the flexible dosing regimen of MoxDuo(TM) IR achieved significantly greater pain relief than those receiving the low dose formulation (p<0.05).