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Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects

From Somerset Pharmaceuticals, Inc, Tampa, Florida (Dr Azzaro, Dr VanDenBerg, Dr Blob, Ms Kemper, Dr Sharoky) and Bristol-Myers Squibb, Plainsboro, New Jersey (Dr Oren, Dr Campbell). Each author is an employee of Somerset Pharmaceuticals, Inc or Bristol-Myers Squibb, as indicated above. No authors are Fellows of the American College of Clinical Pharmacology (FCP). Dr VanDenBerg's current affiliation is the Mercer University Southern School of Pharmacy, Atlanta, Georgia.

The oral tyramine pressor test was administered to healthy males during treatment with a selegiline transdermal system (STS; 6 mg/24 h). The tyramine sensitivity factor (TSF) was calculated from the ratio of baseline and on-treatment tyramine pressor doses. The tyramine sensitivity factor value following 9 days of treatment with the selegiline transdermal system was 1.85 ± 0.10. Extended treatment, 33 days, produced a small, clinically nonmeaningful increase in this value. The tyramine sensitivity factor for the selegiline transdermal system was similar to that following treatment with 10 mg/d of oral selegiline capsules but more than 20 times less than observed during tranylcypromine treatment. A larger increase in the tyramine sensitivity factor was observed following extended selegiline transdermal system treatment at a higher dose (12 mg/24 h), which was significantly decreased following coadministration of tyramine capsules with a meal. These results suggest a wide tyramine safety margin for the selegiline transdermal system and provide evidence that the 6-mg/24-h selegiline transdermal system can be administered safely without dietary tyramine restrictions.

Key Words: Selegiline • transdermal • tyramine pressor test • monoamine oxidase inhibitor • depression

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