QRxPharma Releases Additional Phase 3 Data For Q8003IR 'Dual Opioid' Pain Therapy
"While the initial Phase 3 efficacy data demonstrated statistically significant pain reduction activity of Q8003IR at all dose levels, further analysis suggests that the 12mg/8mg dose delivers the best analgesic effect and tolerability profile," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "These data confirm that our patented dual opioid combination of morphine and oxycodone provides synergistic effects on pain relief and is able to achieve equal or better analgesia at materially lower doses than the active opioid comparator while simultaneously reducing incidence levels of specific side effects."
The goal of the double-blind, placebo-controlled Phase 3 study was to compare four different dosage regimens of Q8003IR in patients with moderate to severe post-surgery pain (bunionectomy) and establish the preferred dose parameters. Secondary endpoints included: (1) efficacy relating to the time to onset of analgesia and the duration of effect from a single oral dose and (2) safety as measured by the incidence and intensity of opioid-related adverse events.
Of the patients receiving 12mg/8mg dose of morphine/oxycodone, 58% reported good to excellent global improvement (as compared to 13% for placebo) and demonstrated the greatest dose-response effect (p
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