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Executive Summary

CHATTEM/GLENBROOK PYRILAMINE MALEATE TRIAL GETS "GREEN LIGHT" from FDA as a result of a Dec. 15 OTC drug "feedback meeting." FDA and the two companies agreed on several changes in the design and language of a "consensus protocol" at the meeting. The protocol calls for two independent studies of the effectiveness of 30 mg pyrilamine versus placebo for the treatment of premenstrual and menstrual symptoms in a randomized, double-blind crossover design involving, at a minimum, 72 women. The companies are attempting to gain Category I status for pyrilamine. The ingredient was moved from Category I to Category III in the OTC Menstrual Products Tentative Final Monograph, which was published in November 1988. Under the title of the Nonprescription Drug Manufacturers Association Menstrual Products Task Force, the companies have been working on a consensus protocol for a trial on the effectiveness of pyrilamine on premenstrual and menstrual symptoms. Pyrilamine is an active ingredient in Chattem's OTC menstrual products Pamprin and Premsyn PMS, and in Glenbrook Labs' Midol. Most of the changes in the protocol had been discussed at a July 27 feedback meeting. At the meeting, FDA made suggestions on how certain aspects of the protocol could be strengthened ("The Pink Sheet" Sept. 4, T&G-12). During the Dec. 15 meeting, NDMA Senior VP William Soller, PhD, assured FDA the protocol will be revised to address points raised during the previous meeting.

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