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Pfizer Inc reports top-line results from ALO-02 phase 3 study


Thursday, 23 Jan 2014 08:00am EST 

Pfizer Inc:Says top-line results from a Phase 3 study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic low back pain.Says in this study, ALO-02 met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo.Says this 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.Says the primary efficacy endpoint of the study 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 (just prior to randomization) to the final two weeks of the double-blind treatment period. 

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