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ARTICLE | Clinical News

Oxycodone-naltrexone: Phase III data

October 15, 2012 7:00 AM UTC

Pfizer reported top-line data from the open-label, single-arm, U.S. Phase III Study ALO-02-10-3001 trial in 395 patients with moderate to severe chronic, non-cancer pain showing that the adverse event profile of once- and twice-daily ALO-02 for up to 12 months was as expected based on similar long-term safety studies with other extended-release opioid formulations. The pharma declined to provide details. The most common adverse events were nausea, constipation, vomiting and headache. The most common serious adverse events were acute myocardial infarction (MI), non-cardiac chest pain, pneumonia, convulsion and kidney stones, each of which occurred in 2 patients. The trial enrolled patients with pain lasting at least 3 months that required continuous opioid analgesic for an extended period of time. Of the 395 patients, 77% were opioid-experienced. ...