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Executive Summary

SECTEUR CARBETAPENTANE STUDIES FOR OTC COUGH PRODUCT MUST INCLUDE either clinical trials in patients with acute respiratory infections or mechanism of action studies as well as clinicals in patients with chronic cough, FDA told the Belgian firm at a Dec. 4 OTC feedback meeting. FDA explained the study requirements in response to the UCB subsidiary's proposal to conduct two clinicals with a chronic cough population in support of an indication for acute respiratory infection. Secteur indicated that it would evaluate the two possible clinical tracks for OTC approval. UCB currently markets carbetapentane antitussive products in Europe under the brandnames Toclase, Tuclase, the Tusolven. Carbetapentane had been marketed in the U.S. by Pfizer under a licensing agreement with UCB. Pfizer marketed the cough product as an Rx under the tradename Toclase. FDA noted at the meeting that carbetapentane was classified Category III in the OTC panel report on antitussives and that no firms submitted data in support of moving it to Category I. Setting the time frame for Secteur's data submission, FDA noted that the antitussive final monograph should be published in approximatey six months. FDA said that Secteur, in order to get carbetapentane approved as an OTC, would need to petition for an amendment to the final monograph. The amendment would then be subject to public comment and subsequent FDA review. That process, FDA reported, is likely to take at least a year. Secteur said it plans to use a newly developed cough counting device in its carbetapentane efficacy trials. The device, the firm said, allows subjects to be mobile while providing an accurate count of the number of coughs experienced. The device utilizes a laryngophon which measures cough sounds and a belted gauge that measures chest acceleration. Coughs are counted on a small recorder when simulataneous impulses are sent from the laryngophon and the chest belt. The firm explained that because both impulses are necessary for the recorder to count a cough, extraneous noises and other non-cough events would not be mistakenly counted.

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