Selegiline transdermal system Somerset
by
Mahmood I.
Division of Clinical Trial Design and Analysis,
Center for Biologics Evaluation and Research,
Food & Drug Administration, MD 20852, USA.
Mahmoodi@CBER.fda.gov
Curr Opin Investig Drugs2002 Aug;3(8):1230-3
ABSTRACTSomerset is developing a selegiline transdermal system (STS) for potential use in the treatment of depression. It has also been developed for Alzheimer's disease (AD), Parkinson's disease and attention-deficit hyperactivity disorder (ADHD) [182121], although no development has been reported for AD or ADHD in recent years. Somerset claims the transdermal system could be more effective than the oral formulation of selegiline already marketed [250573]. In May 2001, Somerset filed an NDA with the US FDA for STS for the treatment of depression [410848], however, in March 2002, the company received a 'non-approvable' letter from the FDA requesting additional efficacy data. At this time, Somerset had scheduled a meeting with the FDA to review and clarify their comments [456735]. Selegiline will be co-promoted in the US by Watson, under the terms of a previous agreementSelegiline
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