Somerset Pharmaceuticals has completed its Phase III trial oftransdermal selegiline in patients with Alzheimer's disease, with disappointing results. The company, a joint venture between Watson Pharmaceuticals and Mylan Laboratories, will now conduct a detailed analysis of the study and see if any subgroups of patients were helped by the treatment.
Somerset already markets a tablet formulation of the monoamine oxidase type B inhibitor, called Eldepryl, for the treatment of Parkinson's disease. The hope was that selegiline would offer a new class of drugs with activity against the disease, to complement the new cholinesterase inhibitors reaching world markets (Marketletters passim).
The company reported preliminary data from its Phase III trial last week. The study compared the company's patented selegiline transdermal system (STS) to placebo in 406 patients with Alzheimer's disease, but found that there was no significant difference between the drug and placebo in their effects on ADAS-Cog and CIBIC-Plus rating scales, which are commonly-used outcome measures in Alzheimer's disease drug trials.
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