Pfizer announces top-line phase-3 safety study results

This week, Pfizer has announced the top-line results from a Phase-3 open-label safety study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules).

The investigation looked into patients with moderate-to-severe chronic non-cancer pain with the objective being to evaluate the safety of ALO-02 when taken for up to one year.

Of those who participated in the study, the majority suffered lower back pain (61 per cent) and nearly one-in-five had discomfort from osteoarthritis. Patients enrolled had pain for an average of nine years.

A total of 193 individuals received ALO-02 for six months and 105 for one year as part of the test.

Dr Steven Romano, senior vice-president at Pfizer's Global Primary Care Business Unit, stated that top-line data provided evidence of the long-term safety of the product in patients with this kind of condition regardless of prior prescription opioid treatment.

The review found the most common adverse affects included headaches, nausea, constipation and vomiting, but overall the study supported the safety profile of the investigational analgesic.