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Clinical Pharmacology Study With AZILECT(R) (Rasagiline Tablets) Demonstrated It Does Not Increase Tyramine Sensitivity
Date:6/9/2009

Study Indicated Rasagiline Selectivity for Inhibiting MAO-B at Maximum Approved Dose

KANSAS CITY, Mo., June 9 /PRNewswire/ -- Teva Neuroscience, Inc. today presented results from a clinical pharmacology study in which AZILECT(R) (rasagiline tablets) did not increase the risk of tyramine sensitivity at the maximum approved dose of 1 mg. The presentation was made during the 13th International Congress of Parkinson's Disease and Movement Disorders in Paris, France. This study assessed the potential risk of hypertensive crisis due to the interaction between high doses of oral tyramine and therapeutic doses of rasagiline, which is indicated both as monotherapy in patients with early Parkinson's disease (PD) and as adjunctive treatment in patients receiving levodopa. The study supported the selectivity of rasagiline for inhibition of MAO-B at currently approved doses.

"We are pleased with the results, which met our primary objectives," said Jon Congleton, general manager of Teva Neuroscience. "This study provides continuing evidence of the value of AZILECT. The results demonstrated a low potential for MAO-A and therefore a selectivity for MAO-B inhibition."

The clinical pharmacology trial was a double-blind, placebo-controlled, randomized, dose-ranging study of rasagiline using a positive control (phenelzine) and a comparator drug (selegiline). The study results were based on the Tyramine Sensitivity Factor (TSF), which measures the ratio of tyramine pressor dose before (baseline) and after MAO inhibitor administration. Geometric mean TSFs of all doses of rasagiline were substantially lower than the TSF for phenelzine, a known nonselective MAO inhibitor. TSFs of various doses of rasagiline were comparable to those of selegiline and placebo.

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. Non
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SOURCE Teva Neuroscience, Inc.
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