Loperamide's superior efficacy over currently available antidiarrheals combined with McNeil's OTC marketing experience could enable the Rx-to-OTC switch candidate to capture a "significant" share of the OTC antidiarrheal market, SRI International predicts in a recently-released report on the U.S. OTC marketplace. "Loperamide had U.S. Rx sales of about $20 mil. in 1986, and the OTC formulation will enter an existing OTC market of more than $80 mil.," the SRI report state. "Because the product is substantially more effective than current OTC products, it is likely to capture significant market share when backed by McNeil's marketing expertise." The market research and perspective report is entitled Winning Competitive Positioning for the Coming U.S. OTC Market Eruption. SRI predicts that Janssen's loperamide (Imodium) will be the next acute care Rx product to be available as an OTC. FDA's Gastro-Intestinal Drugs Advisory Committee recommended approval for an OTC dosage strength of loperamide in December 1986 ("The Pink Sheet" Dec. 15, T&G-2). The advisory committee's approval recommendation was for 48-hour use in nonspecific diarrhea with a warning if symptoms persist. The committee also stipulated that the drug should be contraindicated in patients with a fever of more than 101 degrees F. McNeil proposed a 1 mg OTC formulation with recommended dosage of 2-4 mg to initiate treatment followed by 1-2 mg thereafter. Imodium's approved Rx dosage is 4 mg initially followed by 2 mg thereafter. One study presented by McNeil looked at the 2 mg starting dose followed by 1 mg. J&J is looking to establish an OTC loperamide spin-off from Imodium that carries a slightly different label in order not to cannibalize Rx sales. "McNeil's desire to protect its sister company's Rx franchise was apparent [at the advisory committee meeting]," SRI pointed out, "when it stated that the OTC labeling would be 'very, very different' from the Rx labeling." In fact, SRI predicted, "the difference will be relatively minor. Loperamide's Rx indications include chronic (i.e. longer than 2 days) as well as acute diarrhea, while the OTC form will likely be indicated for acute use." With loperamide's patent expiration in 1990, SRI noted that with a quick approval, "McNeil could gain 2 to 3 years of complete exclusivity." Even if approval is delayed, SRI noted, "the potential exists for 3 years' marketing under Waxman/Hatch Act." However, SRI suggested that McNeil potentially could run into some difficulty with FDA in getting OTC exclusivity because of its submission of only one study at the OTC dose. "It could be argued -- by FDA and/or competitors -- that the one study on the new dosage does not constitute "studies essential" to the approval, as required by the [Waxman/Hatch] act," SRI cautioned. In addition to McNeil, there could be other companies looking at imminent Rx-to-OTC switch candidates in the antidiarrheal class. Searle, for example, has recently said several times that it is looking at reestablishing an OTC business ("The Pink Sheet" Oct. 5, T&G-13). A likely switch candidate in Searle's Rx line is its antidiarrheal Lomotil (diphenoxylate with atropine), which went off patent in 1985. However, an attempt to move diphenoxlyate/atropine to OTC could be complicated by the drug's Schedule V status and its severe effects when overdosed. Among other switch candidates identified by SRI are Merrell Dow's nonsedating antihistamine terfenadine; Schering-Plough's older antihistamine product dexchlorpheniramine; DuPont's benzonatate, which has already been suggested for a switch by FDA as an OTC cough/cold treatment; intranasal interferon for cold prevention, which has been licensed by Rich-Vicks from Cetus; would healing products silver sulfadiazine, marketed by Marion, and Elase, marketed by Parke-Davis; Reed & Carnrick's lindane; and Stiefel's wart remover Duofilm. The SRI report notes the strategic importance of having "follow-up" compounds in the pipeline to protect a prescription franchise when moving an established product to OTC. As an example, SRI cites Schering-Plough, which "has successfully developed dexchlorpheniramine while switching chlorpheniramine to OTC status." SRI predicted that when Schering's new nonsedating anti-histamine loratidine is approved, "efforts may be made to switch dexchlorpheniramine." Loratidine received an FDA advisory committee recommendation for approval on Oct. 23. Commenting on recurrent care Rx compounds that are likely candidates for an OTC switch, SRI highlighted a group of anti-ulcer agents, including cimetidine (Tagamet), ranitidine (Zantac) and sucralfate (Carafate). "SmithKline is reportedly working on nonulcer claims [for OTC cimetidine] such as gastroesophageal reflux," SRI noted. The research report predicts that OTC cimetidine will be availble in "some indications before patent expiry, and that ulcer related claims will be pursued more aggressively after generic sales begin to decimate Tagamet's $500 mil. U.S. sales." The two-volume SRI report also discusses potential OTC candidates among Rx chronic care products as well as general trends affecting the OTC market, the current OTC "universe," OTC marketing, the effects of technology on distribution and sales, and the outlook for OTC industry competition. The two-volume set is priced at $4,500, with each volume available separately for $2,500. SRI International is a market research/consulting firm based in Menlo Park, Calif.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1987 F-D-C Reports, Inc., The Pink Sheet, November 9, 1987
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