While combination analgesic products, such as an NSAID plus an opioid (eg, Vicodin® or Percocet®) are widely used, at present there are no combination products available commercially anywhere in the world containing two opioids. Dual Opioid® technology refers to the use of two opioids that bind to different opioid receptor subtypes, thus providing fewer side effects and/or improved efficacy thereby lowering the dose needed to achieve pain relief and allowing increases in doses for better pain relief if necessary, ie a better therapeutic profile.
QRxPharma is developing three proprietary Dual Opioid formulations for use by the oral (IR—immediate release, CR—controlled release) and parenteral (PCA—patient controlled analgesia) routes in patients with moderate to severe acute or chronic pain. The lead product is MoxDuo® IR (Q8003), a Phase 3 stage fixed ratio combination of morphine sulfate and oxycodone HCl available in immediate release capsule strengths of 3mg/2mg, 6mg/4mg and 12mg/8mg.
Based on results of phase 2-3 trials and preclinical studies, the following benefits are envisaged for patients with moderate-severe pain of an acute or chronic nature when receiving Dual Opioid treatment relative to current opioid regimens:
Fewer (25-75% decreases) adverse events or less intense adverse events than equi-analgesic monotherapy with morphine or oxycodone:
Overall, this superior therapeutic profile allows patients to achieve improved analgesic effects when dose titration or flexible dosing regimens are used.
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