Selegiline transdermal system Somerset.
Somerset 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 agreement [275389].
Mahmood
Iftekhar
I
Division of Clinical Trial Design and Analysis, Center for Biologics Evaluation and Research, Food & Drug Administration, MD 20852, USA. Mahmoodi@CBER.fda.gov
D000279:Administration, Cutaneous; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000075202:Contraindications; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012642:Selegiline / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013329:Structure-Activity Relationship
D000928:Antidepressive Agents; D018491:Dopamine Agonists; D008996:Monoamine Oxidase Inhibitors; D012642:Selegiline