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news.Alpharma has presented positive results from its Phase III placebo-controlled multi-center efficacy trial for its abuse-deterrent, extended-release opioid ALO-01.
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In this trial of over 500 patients, ALO-01 demonstrated significant pain relief. This primary endpoint was agreed to by the FDA via the special protocol assessment process.
The company plans to file marketing application for ALO-01, its extended-release opioid, in the first half of 2008.
Dean Mitchell, president and CEO of Alpharma, said: “These positive clinical results will support the NDA filing for ALO-01 we are targeting for the first half of 2008. We believe that abuse deterrent products will play a significant role in the treatment of pain, and ALO-01 has the potential to be a breakthrough product.”