Pfizer

Pfizer has announced positive top-line results from its phase III long-term safety study of investigational agent ALO-02 in patients with moderate-to-severe chronic, non-cancer pain.

The open-label safety study was designed to assess the safety of ALO-02, comprising oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, administered for up to 12 months.

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The study supported the safety profile of the investigational analgesic and demonstrated that the adverse event profile was as expected based on similar long-term safety studies with other extended-release opioid formulations.

Pfizer Global Primary Care Business Unit Medicines Development Group 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."

Study ALO-02-10-3001 enrolled 395 patients, 77% of whom were opioid-experienced, while 193 patients received ALO-02 for approximately six months and 105 patients for approximately one year.

Nausea, constipation, vomiting and headache were most common treatment-emergent adverse observed while on ALO-02.

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The most common serious adverse events observed were acute myocardial infarction, non-cardiac chest pain, pneumonia, convulsion, and kidney stones, all of which occurred in two patients.

ALO-02 leverages a technology designed to encourage use as intended and discourage common methods of tampering associated with prescription opioid misuse and abuse and consists of extended-release oxycodone pellets that surround a sequestered core of naltrexone.

Image: Pfizer ALO-02 demonstrated its safety profile in a phase III study. Photo: Jim.henderson.