Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

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Home » News & Media » Press Releases » Pfizer Reports Top-Line Results From ALO-02 Phase 3 Study
Pfizer Reports Top-Line Results From ALO-02 Phase 3 Study
Thursday, January 23, 2014 - 8:00am
EST
Pfizer Inc. (NYSE: PFE) announced today 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. In this study, ALO-02 met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo.

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. Patients who achieved a stable and effective dose of ALO-02 (10-80 mg twice per day) during the 4-to-6 week, open-label titration period were randomized (n=281) to the 12-week, double-blind period in which they were either maintained on their current dose regimen of ALO-02 (n=147) or were tapered to placebo (n=134). 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. Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0=no pain, 10=worst possible pain). Mean changes in the primary endpoint, NRS-Pain scores from baseline to the final 2 weeks, were significantly different between ALO-02 and placebo.

The most common adverse events with ALO-2 during the double-blind period in this study were nausea, vomiting and diarrhea.

Results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.

About ALO-02
ALO-02 contains pellets that consist of extended-release oxycodone hydrochloride, an opioid agonist, that surrounds sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, the naltrexone remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released and is designed to counteract the effects of oxycodone.

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