QRxPharma has completed its pilot study to evaluate the analgesic efficacy and safety profile of MoxDuo IR capsules in patients with moderate to severe pain following total knee replacement surgery.
MoxDuo IR is the first patented analgesic product consists of two opioid drugs (a fixed ratio of morphine and oxycodone).
Reportedly, when compared at equianalgesic doses with Percocet, MoxDuo IR demonstrated greater overall tolerability with substantially fewer incidences of moderate to severe nausea, vomiting, constipation, and hypotension than Percocet.
Study results with MoxDuo IR consistently demonstrate fewer side effects than observed with morphine alone, oxycodone alone and now with Percocet.
In the 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.
The study met all primary objectives comparing, the analgesic efficacy and safety profile of MoxDuo IR against control groups of patients receiving Percocet, and a flexible dosing regimen of MoxDuo IR against a fixed low dose (3/2mg). Patients receiving the flexible dosing regimen of MoxDuo IR achieved significantly greater pain relief than those receiving the low dose formulation.
John Holaday, managing director and CEO, QrxPharma, said: 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. 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.