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.
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.
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.