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Executive Summary

ELDEPRYL FIRST LINE USE IN PARKINSON'S DISEASE is recommended by researchers Ira Shoulson, MD, University of Rochester, et al., in a study published in the Nov. 16 issue of The New England Journal of Medicine. "Even if the effect . . . is entirely symptomatic, patients with Parkinson's disease so treated in the early stages of illness should be able to function longer before requiring levodopa therapy," Shoulson, the principal investigator of The Parkinson Study Group, wrote. Eldepryl (deprenyl or selegiline) was approved in June as an adjunct to levodopa and carbidopa. The drug was developed for the indication by Denville, New Jersey-based Somerset Labs, which licenses the selective monoamine oxidase inhibitor from the Hungarian firm Chinoin. Prior to its approval, the drug was distributed under a Treatment IND. In November 1988, Somerset was purchased by a Bolar/Mylan joint venture. The Shoulson study, which is still ongoing, randomized 800 untreated Parkinson's patients to receive deprenyl, tocopherol (vitamin E), a combination of both drugs, or placebo. The primary endpoint was defined as the onset of disability sufficient to require levodopa therapy. Comparing the 401 subjects assigned to tocopherol or placebo with the 399 receiving deprenyl 10 mg/day either alone or with tocopherol, researchers found that only 97 on deprenyl reached the endpoint over an average period of 12 months compared to 176 patients not receiving deprenyl. According to the study, the risk of reaching the endpoint was reduced by 57% in the deprenyl group. The researchers hypothesize that deprenyl's inhibiting action on monoamine oxidase could act to prevent nigral degeneration and the turnover of dopamine. Ironically, the study, which could lead to an expanded market for Eldepryl, was published on the same day that the Senate Aging Committee conducting a hearing on the cost of prescription drugs. Eldepryl was one of three drugs on Sen. David Pryor's (D-Ark.) committee's agenda (see story, p. 14). The annual patient cost for Eldepryl is estimated at $ 1,375. Originally developed as an antidepressant, the drug has been available in Europe for a number of years as an adjunct to levodopa in Parkinson's.

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