Rotigotine: The first new chemical entity for transdermal drug delivery

• Rotigotine is the first new chemical entity which was developed for transdermal delivery.
• The development, preformulation and formulation programmes for rotigotine are described in this review.
• Alternative approaches for skin delivery of rotigotine are discussed.

Rotigotine is the first, and to date, the only new chemical entity to be formulated for transdermal delivery. Although first approved for the management of Parkinson’s disease in Europe in 2007 and Restless Leg Syndrome in 2008, the story of rotigotine began more than twenty years earlier. In this review we outline the historical development of this molecule and its route to licensed medicine status. It has very favourable physicochemical properties for transdermal delivery but it took a significant period to develop from concept to market. The stability problems which led to the temporary withdrawal of the patch are examined and the major clinical studies demonstrating efficacy and safety are outlined. Alternative new therapeutic modalities are also considered.

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