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Executive Summary

McNeil's OTC loperamide (Imodium A-D) was approved in the same dosage strength and with the same initial dosing regimen as Janssen's prescription Imodium product. Labeling for the OTC, approved in a 1 mg/5 ml (1 tsp.) liquid formulation, directs adults to "take four teaspoons after first loose bowel movement, [and], if needed, take 2 teaspoons after each subsequent loose bowel movement." Prescription Imodium, supplied in 2 mg capsules and 1 mg/5 ml liquid, also directs adults to take an initial 4 mg dose, followed by a 2 mg dose. Maximum daily dosage for the OTC product, however, is 8 mg, compared to 16 mg for the prescription product. FDA approved the OTC product March 3, roughly 15 months after a recommendation by the agency's Gastrointestinal Drugs Advisory Committee. McNeil said it expects the Imodium A-D to be available at the retail level by the Labor Day holiday in early September. At the advisory committee meeting, McNeil had proposed that the OTC loperamide version be labeled for a 2-4 mg starting dose, followed by a 1-2 mg dose. The advisory committee divided on whether the dose should be in the proposed range or lower. However, FDA Cardio-Renal Division Director Raymond Lipicky, MD, advised the committee that since there are no dose-related, limiting side effects associated with loperamide, a large starting dose might be desirable to obtain quick relief. The label's warnings section follows the advisory committee's recommendations that the product not be used in patients with a high fever, blood in stools, or in patients with diarrhea persisting for more than 48 hours, unless advised by a physician. The labeling states: "Warnings: Do not use for more than two days unless directed by a physician. Do not use if diarrhea is accompanied by high fever (greater than 101 F), or if blood is present in the stool, or if you have had a rash or other allergic reaction to loperamide HCI." In the indications section, the labeling states that the product "controls the symptoms of diarrhea." Prescription Imodium is indicated for chronic diarrhea associated with inflammatory bowel disease as well as for the OTC indication for short term use in relief of diarrhea. Johnson & Johnson's patent on loperamide expires in January 1990. Because the firm submitted a full NDA for the OTC product containing new clinical trials, the OTC version may qualify for three years exclusivity under provisions of the Waxman/Hatch low. However, approval of the OTC product in the same dosage strength could make a grant of exclusivity less likely. Under the law, new studies must have been "essential" to the approval of a new formulation of the same product to qualify for exclusivity. In a recent report by SRI International, the research consulting firm pointed out that NcNeil might have difficulty obtaining exclusivity because the company conducted only one study at a dosage less than the approved prescription strength. McNeil said it has not yet filed for exclusivity. The SRI report, released in late-1987, predicted that the OTC formulation would be able to capture a significant share of the $80 mil. OTC antidiarrheal market. "Because the product is substantially more effective than current OTC products, it is likely to capture significant market when backed by McNeil's marketing expertise," the report said. Prescription strength loperamide had annual sales of approximately $20 mil. in 1986. according to the report.

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