Teva Neuroscience Inc. today announced the publication of a study demonstrating the selectivity of Azilect® (rasagiline tablets) for inhibition of MAO-B (monoamine oxidase-B) at the maximum approved dose of 1 mg/day. The data was published in the Journal of Clinical Pharmacology OnlineFirst on May 5, 2010.
“With the confirmation of Azilect® as a selective MAO-B inhibitor, and the change in the official prescribing information about dietary tyramine, a potential treatment barrier has been removed. Patients and physicians can continue to focus on what's important - managing the disease.”
This study was submitted to the Food and Drug Administration (FDA) and became the basis for the change in prescribing information that removed the broad dietary tyramine restriction, reflecting reduced concerns regarding the use of Azilect® together with certain medications, including many over-the-counter cough/cold medications. Confirmation of the MAO-B selectivity of Azilect® that is shown in this study is significant as MAO inhibitors that are non-selective interfere with the breakdown and elimination of tyramine in the body, which can induce hypertensive reactions. Selective MAO-B inhibitors, like Azilect®, do not generally interfere with tyramine breakdown and elimination at recommended doses.
"Multiple studies have demonstrated that Azilect® may play an important role in the treatment of Parkinson's disease, both as monotherapy and as adjunctive therapy," said Daniel Kremens, M.D., assistant professor of neurology and co-director of the Parkinson's disease and Movement Disorders Division at Jefferson Medical College of Thomas Jefferson University in Philadelphia. "With the confirmation of Azilect® as a selective MAO-B inhibitor, and the change in the official prescribing information about dietary tyramine, a potential treatment barrier has been removed. Patients and physicians can continue to focus on what's important - managing the disease."
Tyramine is an amino acid found in certain foods and beverages, including some air-dried and fermented meats, some aged cheeses and most soybean products. Elevated levels of tyramine can cause a serious increase in blood pressure. Ingestion of very high levels (e.g., more than 150 mg) of tyramine by patients taking MAO inhibitors, including Azilect®, should be avoided.
An estimated five million people worldwide have Parkinson's disease, an age-related degenerative disorder of the brain that can cause tremors, stiffness, slowness of movement and impaired balance.