These side effects were dose-dependent.

Mechanism of Action

Avinza is made up of two components: an immediate-release component that rapidly achieves plateau morphine concentrations in plasma, and an extended-release component that maintains plasma concentrations throughout the 24-hour dosing interval. Avinza creates and maintains the plateau-like plasma concentration profile after steady-state plasma morphine concentrations have been achieved.

Clinical Results

Controlled and open-label clinical trials were conducted to test the safety and efficacy of Avinza. A total of approximately 140 healthy subjects and 560 subjects with chronic, moderate-to-severe pain from malignant and non-malignant disease sources were involved in these studies. The duration of the controlled clinical studies ranged from seven days to up to four weeks. Subjects in the open-label studies were observed for six to 12 months.

In one study, 295 subjects with chronic pain from osteoarthritis received either placebo or once-daily treatment with Avinza 30 mg in the morning or evening. Results showed that Avinza was significantly more effective at reducing pain than placebo.

Pharmacokinetic studies indicated that the amount of morphine absorbed from Avinza extended-release formulation was similar to that absorbed from other oral morphine formulations. Furthermore, the pharmacokinetics of Avinza were shown to be dose-proportional for both healthy subjects and subjects with moderate-to-severe pain.