Selegiline Transdermal System (STS): Preclinical Assays of Dermal Safety

Two preclinical sensitization studies were conducted to determine the potential for allergic contact dermatitis with the selegiline transdermal system (STS), a novel transdermal system being developed to treat major depressive disorder. These included a qualitative structure‐activity relationship (QSAR) analysis to assess the allergic dermatitis potential of selegiline, and a guinea pig dermal sensitization study to determine the delayed contact hypersensitivity potential of the STS. In the QSAR analysis, selegiline was classified as a nonallergen. In the guinea pig study, the STS was found not to act as a dermal sensitizer. Thus, based upon the results of these two preclinical studies, treatment with the STS is unlikely to pose a risk of causing significant allergic contact dermatitis. Human data, reported elsewhere, support this hypothesis.