selective MAO inhibitors, such as phenelzine sulfate, interfere with the breakdown and elimination of tyramine in the body. Selective MAO-B inhibitors do not interfere with tyramine breakdown and elimination. Patients who take nonselective MAO inhibitors need to be cautious with the foods they eat to prevent an abnormal build-up of tyramine, which could lead to an episode of extremely high blood pressure, potentially leading to stroke or heart attack.
This study was performed as part of a Phase IV commitment to the U.S. Food and Drug Administration (FDA) at the time of AZILECT approval. The results of this study have been submitted to FDA, and Teva Neuroscience intends to work with FDA to appropriately incorporate these results into the label for AZILECT.
About the Study
The tyramine trial was a double-blind, placebo-controlled, randomized, dose-ranging study of rasagiline using a positive control (phenelzine) and a comparator drug (selegiline). In the study, 179 healthy male and female volunteers, aged 40 to 70 years, entered a run-in tyramine challenge test with 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 3 consecutive increases from baseline in SBP >/=30 mm Hg over >/=10 minutes (tyramine pressor dose) in period 1 divided by the dose associated with the same change in SBP in period 3. Nonselective comparator, phenelzine, caused the highest geometric mean TSF of 17.32 +/- 12.76. Geometric mean TSF for rasagiline 1 mg once daily, the maximum approved dose, was 2.03 compared with 1.50 for pooled placebo and 2.47 for selegiline.
AZILECT(R) (rasagiline tablets) is indicated for the treatment of the signs and symptoms of Parkinson's disease (PD) both as initial therapy alone and to be added to levodopa later in the disease.
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