ALO-02 Shows Top-Line Results in Phase 3 Trial
Pfizer announced that the investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) has met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo in patients with moderate-to-severe chronic low back pain.
In the double-blind, placebo-controlled, randomized withdrawal design efficacy and safety study, patients who achieved a stable and effective dose of ALO-02 10–80mg twice per day during the 4-to-6 week, open-label titration period were randomized (n=281) to a 12-week period in which they maintained their current dose regimen (n=147) or were tapered to placebo (n=134). The difference between ALO-02 and placebo in the mean change in the daily average 11-point pain numerical rating scale (NRS-Pain) scores from baseline to the last two weeks of the double-blind treatment period was defined as the primary efficacy endpoint. The mean changes were significantly different between ALO-02 and placebo.
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