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J&J SEEKING LOPERAMIDE Rx-TO-OTC SWITCH THROUGH NDA ROUTE; FDA's

Executive Summary

J&J SEEKING LOPERAMIDE Rx-TO-OTC SWITCH THROUGH NDA ROUTE; FDA's Gastrointestinal Advisory Committee will review McNeil Consumer Products' NDA for the OTC antidiarrheal at its Dec. 8-9 meeting. Janssen currently markets Rx loperamide (Imodium) in 2 mg capsules and in a liquid formulation. Imodium, marketed in capsule form since 1977, is indicated for "the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease." Imodium is also labeled for "reducing the volume of discharge from ileostomies." According to FDA's announcement of the upcoming advisory committee meeting, the OTC NDA will be evaluated for "diarrhea and associated cramps." If clinical trials are required for the OTC loperamide NDA, the product, when approved, will presumably receive three years of marketing exclusivity under the Waxman/Hatch law. To date, J&J has been the sole marketer of Rx loperamide. Imodium is estimated to have been in the bottom quarter of the top 200 drugs in 1985 retail sales. Loperamide appears to have good potential as an OTC antidiarrheal. The ingredient, along with diphenoxylate and bismuth subsalicylate, was recommended as first line treatment for travelers diarrhea at an National Institutes of Health Consensus Conference in January 1985. In addition, labeling for Imodium characterizes the drug as having a fairly low side-effect profile. Approved labeling states that the "adverse effects reported during clinical investigations of Imodium are difficult to distinguish from symptoms associated with the diarrheal syndrome." Adverse experiences seen during trials, the labeling continues, "were generally of a minor and self-limiting nature." Rx-to-OTC switches have been relatively sparse in the last few years. However, FDA's advisory committees have reviewed at least two switch candidates in the last two years. FDA's Dermatologic Drugs Advisory Committee voted four-in-favor to four-against making 1% hydrocortisone available OTC at its November 1985 meeting ("The Pink Sheet" Nov. 25, 1985, p. 8). Upjohn had filed an NDA for 1% hydrocortisone and Combe subsequently petitioned FDA to allow marketing via a change in the OTC monograph rather than by an NDA. In May, FDA's Pulmonary-Allergy Drugs Advisory Committee met to discuss for the second time the switch to OTC status of metered dose inhaler bronchodilators ("The Pink Sheet" May 26, p. 5). At that meeting, Boehringer Ingelheim announced that it was withdrawing its supplemental NDA for OTC marketing of its brochodilator Alupent (metaproterenol). Sterling, however, told the committee that it would continue to pursue an Rx-to-OTC switch for its bronchodilator Bronkometer (isoetharine). Sterling, in a recent presentation to analysts, indicated that its Glenbrook Labs OTC business is committed to using the Rx-to-OTC switch route as a source of new products.
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