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CYANAMID VIPROSTOL PHASE III BALDNESS STUDIES WILL INCLUDE 1,000

Executive Summary

CYANAMID VIPROSTOL PHASE III BALDNESS STUDIES WILL INCLUDE 1,000 male volunteers from 30 centers in the U.S., the company reported in a Sept. 25 release. The volunteer pool will be equally divided into three groups, Cyanamid said, with one group receiving viprostol in the same carrier used in Phase II studies; one group receiving just the carrier lotion without the drug; and one group receiving placebo. Cyanamid said it has begun to enroll volunteers and expects the study to be underway by the end of 1986/early 1987. Cyanamid recently completed a Phase II study of viprostol in male pattern baldness at eight centers in 150 male volunteers. Commenting on the recently completed Phase II studies, Cyanamid Exec VP Jack Bowman said: "In our opinion, the results of these clinical studies . . . justified an expansion of the trials into Phase III," However, he added the disclaimer: "it is too early in the clinical process to determine whether this research program will lead to an efficacious product." Bowman added that Cyanamid "normally would not report on the clinical process at this stage, but was doing so only in response to strong public interest." If the results of the Phase III trials are positive, viprostol will enter the race to be the first Rx hair-growing drug. Upjohn's Rogaine (minoxidil) already has a substantial head start; an NDA for the topical formulation of the antihypertensive Loniten was filed with FDA in December 1985.

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