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news.Pfizer has reported positive top-line results from a Phase 3 open-label long-term safety study of ALO-02, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, in patients with moderate-to-severe chronic, non-cancer pain.
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Study ALO-02-10-3001 included adult patients with moderate-to-severe chronic non-cancer pain lasting at least three months and requiring a continuous around-the-clock opioid analgesic for an extended period of time.
The trial was designed to evaluate the safety of ALO-02 administered for up to 12 months.
Pfizer Global Primary Care Business Unit Medicines Development Group head, senior vice president Steven Romano said, "These top-line data provide evidence of the long-term safety of ALO-02 in patients with moderate-to-severe non-cancer pain regardless of prior prescription opioid treatment."
The study demonstrated that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opioid formulations.
Most common adverse events observed in the study, which supports the safety profile of the investigational analgesic, were nausea, constipation, vomiting and headache.