FDA Approves Newly Revised Prescribing Information For Azilect® Reducing Medication And Food Restrictions
Jersulam, Israel, December 14, 2009 - Teva Pharmaceutical Industries, Ltd. (NASDAQ:TEVA) today announced the U.S. Food and Drug Administration (FDA) approved the newly revised prescribing information for AZILECT® (rasagiline tablets) reducing medication and food restrictions. This update was based on clinical data that confirmed the mechanism of action of AZILECT® as a selective MAO-B (monoamine oxidase-B) inhibitor at the recommended doses of 1 mg and 0.5 mg.
The newly approved prescribing information reflects reduced concerns regarding the use of AZILECT® together with certain medications, including many over-the-counter cough/cold medications. In addition, patients taking AZILECT® no longer need to follow a general dietary restriction of ordinary levels of tyramine, an amino acid found in certain foods and beverages, such as air-dried and fermented meats, aged cheeses and most soybean products. However, due to potential mild increased sensitivity in some patients, ingestion of very high levels of tyramine (e.g., >150 mg) should be avoided by patients taking MAO inhibitors.
"The FDA's decision to modify the AZILECT® prescribing information emphasizes the benefit to patients of AZILECT® MAO-B selectivity at recommended doses," 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. "This is good news for patients and physicians as it reconfirms the safety and convenience of AZILECT®."
"We are pleased with this important change in the prescribing information of AZILECT® as it removes a barrier for some physicians, and some patients, living with Parkinson's disease," said Jon Congleton, VP and General Manager, U.S., Teva Neuroscience. "Physicians can now better focus on what is really most important, which is helping patients receive a proven efficacious and safe treatment, at diagnosis early in Parkinson's disease, and throughout the course of the disease."
About the Tyramine Study
The tyramine study, submitted to the FDA as the basis for the change in the prescribing information, supported the selectivity of AZILECT® for inhibition of MAO-B at approved doses, 1 mg and 0.5 mg. Non selective MAO inhibitors may interfere with the breakdown and elimination of tyramine in the body, which can induce hypertensive reactions.
The tyramine study was a double-blind, placebo-controlled, randomized, dose-ranging study of rasagiline using a positive control (phenelzine), a known non-selective MAO inhibitor, and a comparator drug (selegiline). This study was part of a Phase IV commitment to the FDA at the time of AZILECT® approval. The study results were based on Tyramine Sensitivity Factor (TSF), which measures the ratio of tyramine pressor dose before (baseline) and after MAO inhibitor administration.
In the study, 179 healthy male and female volunteers, aged 40 to 70 years received escalating doses of oral tyramine from 25 mg up to 800 mg administered under fasting conditions. TSF was calculated as the tyramine dose associated with three consecutive increases from baseline in systolic blood pressure (SBP) 30 mm Hg over 10 minutes (tyramine pressor dose) in period one divided by the dose associated with the same change in SBP in period three.
Geometric mean TSFs of all doses of rasagiline were substantially lower than the TSF for phenelzine. TSFs of various doses of rasagiline were comparable to those of selegiline and placebo.
AZILECT® (rasagiline tablets) is indicated for the treatment of the signs and symptoms of Parkinson's disease (PD) as initial therapy alone and to be added to levodopa later in the disease.
AZILECT® is now available in 39 countries, including the U.S., Canada, Israel, Mexico and all of the European Union countries, where it is marketed by Teva in collaboration with Lundbeck A/S as part of a long-term strategic alliance.
About Parkinson's disease
Parkinson's disease is an age-related degenerative disorder of the brain. Symptoms can include: tremor, stiffness, slowness of movement, and impaired balance. An estimated five million people worldwide suffer from the disease, with an average age of onset of about 60 years.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.
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