Pfizer phase 3 chronic, non-cancer pain drug results
Pfizer has announced results from a phase 3 clinical study of its investigational agent ALO-02 in patients with moderate-to-severe chronic, non-cancer pain.
The primary objective of the study was to evaluate the safety of ALO-02 (oxycodone hydrochloride and naltexone hydrochloride extended-release capsules) administered for up to 12 months.
“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.”
Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.
A total of 295 patients were involved in the clinical trials. About 61% of the patients had chronic lower back pain and 18% had pain from osteoarthritis. Patients enrolled in the study had pain for an average of nine years.
The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opiod formulations.
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