Pfizer says top-line Ph III results show safety of pain drug ALO-02 as expected
US pharma behemoth Pfizer (NYSE: PFE) said yesterday that top-line results from a Phase III open-label long-term safety study of its investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, non-cancer pain support the product’s safety profile compared to rival opioids.
The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opioid formulations; the most common adverse events were nausea, constipation, vomiting and headache. The study supports the safety profile of this investigational analgesic.
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