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news.Alpharma has announced promising results from its Phase III pivotal efficacy trial that showed ALO-01 capsules provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared to placebo. The findings also showed that ALO-01 capsules were safe and well-tolerated.
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According to the study findings, patients who were taking ALO-01 capsules reported significantly more effective pain relief, as measured by mean change in the weekly brief pain inventory (BPI) average pain intensity score from baseline to the 12-week endpoint of the study, compared to patients who were taking placebo. Additionally, 72.5% of patients reported taking ALO-01 experienced pain relief of at least 30% from baseline, compared to 57.8% patients given placebo.
The 12-week, double-blind, randomized, placebo-controlled enriched enrollment Phase III pivotal trial assessed the effectiveness of ALO-01 capsules when compared with placebo in 344 adult patients with moderate to severe pain due to osteoarthritis of the hip or knee. After a screening and washout period from previous treatments (less than or equal to 14 days), patients were administered two periods of treatment with study drugs.
Patients were first titrated to effective pain management levels with ALO-01 capsules during open label titration, they were then randomized to double-blind treatment with either ALO-01 capsules or placebo for 12 weeks. Study participants were allowed to use acetaminophen as a rescue medication, up to 500 mg every six hours, as needed.
Safety and tolerability included measurements by rates of self-reported adverse events and a measure of opioid withdrawal, an indication of naltrexone leakage from the capsules, called clinical opiate withdrawal scores (COWS). ALO-01 capsules were safe and well-tolerated in this study, with an overall safety profile consistent with that of other opioid products. COWS data suggest that naltrexone did not leak out of the capsules, and there was no increased risk of opioid withdrawal versus placebo.
Joseph Stauffer, CMO and senior vice president of clinical research & medical affairs at Alpharma, said: “We look forward to collaborating with the FDA during the review process for ALO-01, which, if approved, would be the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain.”