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Medical Areas: Musculoskeletal | Neurology | Family Medicine
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Avinza (morphine sulfate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Elan Pharmaceuticals
Approval Status: Approved March 2002
Treatment Area: Chronic pain
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.
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
The most common side effects reported by subjects in clinical
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
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.