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ELDEPRYL IN EARLY PARKINSON's: DISEASE PROGRESSION SLOWED 40%-83%

Executive Summary

ELDEPRYL IN EARLY PARKINSON's: DISEASE PROGRESSION SLOWED 40%-83% per year compared to placebo based on five clinical measures, a study published in the Aug. 4 issue of Science reports. Conducted by James Tetrud and William Langston of the California Parkinson's Foundation, the trial randomly assigned 54 patients with Parkinson's disease for less than five years to receive either Eldepryl (selegiline) 10 mg/day or placebo. Patients were followed until levodopa therapy was indicated or until they had been in the study three years. Eldepryl "appears to be a remarkably safe drug in patients with early, untreated Parkinson's disease," the researchers concluded. "We failed to observe any serious side effects, and the minor complications that did occur were almost evenly divided between the placebo group and the drug group." In addition, early Eldepryl therapy "significantly delays the need for treatment with L-dopa," the study says. On June 5, FDA approved the orphan product as an adjunct to levodopa and carbidopa in refractory Parkinson's patients. The recommended dose is 5 mg twice a day. The drug has been available under a Treatment IND since June 1988. Somerset Labs, the drug's sponsor, plans to launch Eldepryl in mid-September, and market the product through a 40-rep sales force. FDA's June approval of Eldepryl cleared the way for an acquisition of Somerset by two generic drug firms, Mylan and Bolar. The U.S. rights to selegilene are licensed from the Hungarian firm Chinoin, which will be manufacturing the drug for Somerset. In addition to the California trial, Eldepryl's use as a first-line therapy is also being studied by the National Institutes of Health in a three-year study that began in 1987. NIH is comparing the drug to vitamin E alone, to a combination of Eldepryl and vitamin E, and to a placebo. The endpoint for that study is initiation of levodopa therapy.
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