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O'CONNOR VAPORIZER IN A BOTTLE STUDY

Executive Summary

O'CONNOR VAPORIZER IN A BOTTLE STUDY v. VICK'S VAPORUB will be conducted, consultant David Cohen, PhD, told FDA at a recent OTC Drug Feedback Meeting. O'Connor is attempting to demonstrate the bioequivalence of Vaporizer in a Bottle (VIAB) to Rich-Vick's Vaporub for a Category I antitussive claim in the tentative final monograph for cough/cold combinations. The study will analyze the composition of VIAB vapors at distances of six to 24 inches in comparison with Vaporub. VIAB is characteristically used at a distance of 18-24 inches, for example, on a nightstand next to the bed, Cohen explained. O'Connor is planning to submit the study method and protocol for gas chromatography analysis to FDA's OTC Division before beginning the study. O'Connor has decided to drop its decongestant claim for VIAB, Cohen noted. Rich-Vicks has been conducting a study to support Category I status for Vaporub as a nasal decongestant. The decongestant claim is currently Category III. O'Connor is also dropping its claim that VIAB has a duration of 200 hours. "I don't believe that we can maintain that claim," Cohen commented. However, he noted that the new study will measure the duration of vapors over time. "We believe that the area under the curve over time is more meaningful with VIAB than with Vick's Vaporub," Cohen added. At the meeting, FDA expressed some concern about the ingredient methyl salicylate, which is in VIAB but absent from Vaporub. Noting that the agency has not yet determined the purpose of methyl salicylate, FDAer Gerald Rachinow remarked that the agency has "had methyl salicylate problems throughout the OTC review." VIAB contains 4.5% methyl salicylate. In attendance at the feedback meeting were representatives of O'Connor and Columbia Laboratories. The latter acquired a marketing arm of the Michigan-based O'Connor Products last October in a $ 1.3 mil. stock transaction. Miami, Florida-based Columbia was formed in 1986 by a group of former Key Pharmaceutical executives. Key was acquired by Schering-Plough in 1986.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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