General Information

Avinza was approved by the FDA in March 2002 for the treatment of moderate to severe chronic pain in patients that require continuous, around-the-clock therapy for an extended period of time. A once-daily dose of Avinza in the extended release capsule formulation provides relief from pain for a 24-hour period. Avinza is available in 30, 60, 90 and 120 mg capsules.

This product was developed by Elan Corporation and will be marketed in the U.S. and Canada by Ligand Pharmaceuticals.

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.

Side Effects

The most common side effects reported by subjects in clinical trials were:

• constipation
• nausea
• somnolence
• vomiting
• headache

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.

Additional Information

For additional information about Avinza, please visit the Elan Pharmaceuticals web site at www.elanpharma.com, and the Ligand Pharmaceuticals web site at www.ligand.com.