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Alza stops "Stop and Go"

Executive Summary

FDA objects to Alza "Stop and Go" direct-to-consumer campaign for overactive bladder treatment Ditropan XL (oxybutinin) in July 12 letter to company. According to FDA, the print and broadcast campaign overstated the efficacy for the extended-release oxybutinin formulation because it "fails to prominently disclose that the clinical trials were set up to include only patients who the sponsor knew would have improved symptoms on Ditropan XL because they were known to have had improved symptoms on" oxybutinin or other overactive bladder agents. The agency also objected to the prominent display of the graphic "90%" in TV ads, backed by an audio statement that the drug was shown "to reduce wetting accidents by up to 90% versus 51% for a sugar pill." Alza said it has discontinued the "Stop and Go" campaign and all other promotions with similar messages

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