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Selegiline Transdermal System: An Examination of the Potential for CYP450-Dependent Pharmacokinetic Interactions With 3 Psychotropic Medications

From Somerset Pharmaceuticals, Inc, Tampa, Florida (Dr Azzaro, Ms Kemper); Gwynedd Pharmaceutical Consultants, Gwynedd Valley, Pennsylvania (Dr Ziemniak); Bristol-Myers Squibb Co, Plainsboro, New Jersey (Dr Campbell); and Mercer University Southern School of Pharmacy, Atlanta, Georgia (Dr VanDenBerg).

Selegiline transdermal system (STS) is a recently approved monoamine oxidase inhibitor antidepressant. This article reports results from 3 studies examining the potential for cytochrome P450-dependent pharmacokinetic interactions between STS and 3 psychotropic medications that might be coadministered. Three open-label, randomized, Latin square, 3-sequence crossover design studies were conducted with healthy volunteers to determine the pharmacokinetic parameters of STS 6 mg/24 h and test drug (alprazolam, olanzapine, or risperidone) when administered alone and concomitantly. All pharmacokinetic parameters of interest were unaltered following selegiline or test drug monotherapy when compared to concomitant therapy. This was confirmed by least squares mean ratios and their 90% confidence intervals of log_e-transformed C_max and AUC values, using either standard bioequivalence criteria of 80% to 125% or study-defined 70% to 143% boundary criteria. These results demonstrate that STS 6 mg/24 h may provide an antidepressant option that is unlikely to result in CYP450-mediated pharmacokinetic drug-drug interactions.

Key Words: Selegiline • transdermal • drug-drug interactions • pharmacokinetics • cytochrome P450 enzymes

Address for reprints: Address for correspondence: Albert J. Azzaro, PhD, Chief Scientific Officer, Somerset Pharmaceuticals, Inc, Rocky Point Center, 3030 North Rocky Point Drive, Suite 250, Tampa, FL 33607.

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				A. J. Azzaro, C. M. VanDenBerg, J. Ziemniak, E. M. Kemper, L. F. Blob, and B. J. Campbell Evaluation of the Potential for Pharmacodynamic and Pharmacokinetic Drug Interactions Between Selegiline Transdermal System and Two Sympathomimetic Agents (Pseudoephedrine and Phenylpropanolamine) in Healthy Volunteers J. Clin. Pharmacol., August 1, 2007; 47(8): 978 - 990. [Abstract] [Full Text] [PDF]