Ligand Pharmaceuticals Incorporated has been asked to make changes in the label of its sustained-release opiod product, Avinza (once-a-day morphine sulfate extended-release capsules) by the US Food and Drug Administration (FDA).
The recently issued US FDA letter said, "In vitro observations indicate that the extended-release characteristics of Avinza are compromised in the presence of alcohol. Until the clinical implications of these data are fully assessed, we request that changes be made to the package insert," with the intent to provide adequate information for the safe and effective use of the drug. The company has also been asked by the FDA to send a "Dear Health Care Professional Letter" to appropriately inform these professionals of the label changes.
"The Avinza package insert currently carries several precautions about use of the product with alcohol. The FDA suggested changes that would highlight and intensify warnings about alcohol intake while using Avinza," James L'Italien, Ligand's senior vice president for regulatory affairs and compliance said adding, "We're analyzing the FDA's request and are in dialogue with the Agency. We may also need to do additional in vivo translational pharmacokinetic studies to accurately assess which of these label changes or clarifications are ultimately appropriate. We intend to work with the FDA to effect agreed upon label changes and the 'Dear Health Care Professional Letter' promptly."
Avinza (oral morphine sulfate extended-release capsules) is the first true once-a-day treatment for chronic moderate-to-severe pain in patients who require continuous, around-the-clock opioid therapy for an extended period of time. Approved by the FDA in March 2002, AVINZA consists 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 a 24-hour dosing interval. Ligand co-promotes AVINZA with Organon Pharmaceuticals USA Inc. in the United States.