Pfizer Inc. (PFE) reported top-line results of Phase 3 trial of investigational agent ALO-02 in patients with moderate-to-severe chronic low back pain. During this study, ALO-02 met the primary efficacy endpoint, showing a statistically significant difference from placebo.
It was a 12-week, double-blind, placebo-controlled, randomized withdrawal design efficacy and safety study in patients with moderate-to-severe chronic low back pain. Patients who received a stable and effective dose of ALO-02 in the 4-to-6 week, open-label titration period were randomized to the 12-week, double-blind period in which they were either maintained on their current dose regimen of ALO-02 or were tapered to placebo.
The trial's primary efficacy endpoint was defined as the difference between ALO-02 and placebo in the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline to the final two weeks of the double-blind treatment period. The most common adverse events with ALO-2 during the double-blind period in this study were nausea, vomiting and diarrhea.
ALO-02 contains pellets that consist of extended-release oxycodone hydrochloride, an opioid agonist, that surrounds sequestered naltrexone hydrochloride, an opioid receptor antagonist.
The company said the results out of this study would be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
by RTT Staff Writer
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