Selegiline-Transdermal — Somerset

Excerpt

Somerset Pharmaceuticals, a 50/50 joint venture between Watson Pharmaceuticals and Mylan Laboratories, is developing a transdermal formulation of the monoamine oxidase type B inhibitor selegiline [Emsam] for the treatment of depression, Alzheimer’s disease and Parkinson’s disease.¹ Somerset have filed an NDA with the US FDA for the use of the transdermal formulation of selegiline in depression. However, the FDA has deemed the application ‘not approvable’ and is requesting additional efficacy data. The product is also undergoing phase III development in the US for Alzheimer’s disease and Parkinson’s disease. However, initial results in Alzheimer’s disease have not been promising.[1] …