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GERMAN SWITCH POSSIBILITIES INCLUDE LORATADINE, CIMETIDINE, NAPROXEN

This article was originally published in The Tan Sheet

Executive Summary

GERMAN SWITCH POSSIBILITIES INCLUDE LORATADINE, CIMETIDINE, NAPROXEN and ketoprofen, Bundestag member and Deputy Chairman of Germany's Committee for Health Walter Altherr, MD, told a general meeting of the World Federation of Proprietary Medicines Manufacturers in Acapulco, Mexico on Oct. 29. Altherr also indicated that the German government is taking a close look at the switch of nicotine patches to nonprescription status. While Altherr cautioned the audience that switch "decisions by analogy will rarely be possible," he said that the favorable safety profile of the nonsteroidal anti-inflammatory ibuprofen in its years of nonprescription use suggest that "on the basis of the same criteria, ketoprofen and naproxen could also be recommended for a switch." In the U.S., Syntex/P&G's Rx-to-OTC switch application for naproxen sodium is expected to be cleared shortly by FDA, and American Home Products, which markets prescription Orudis (ketoprofen) in this country, said recently that it considers the ketoprofen switch as a "high priority" project. Cimetidine (SmithKline's prescription drug Tagamet) is another attractive switch candidate, Altherr said, because of its efficacy for "gastrointestinal conditions" and "positive benefit-to-risk spectrum." However, he emphasized that he "would evaluate the other H, blockers similarly, so that together with a switch of cimetidine, ranitidine [Lilly's Axid] and famotidine [Merck's Pepcid] could also be considered." Loratadine (Schering-Plough's prescription antihistamine Claritin), although a "relatively new substance," seems to be "a suitable candidate for switch," in part, because it has "practically no sedative effects," Altherr told the group. Altherr pointed out that similar nonsedating antihistamines, Marion Merrell Dow's Seldane (terfenadine) and Johnson & Johnson's Hismanal (astemizole), have been associated with "isolated" cardiovascular side effects. However, both drugs, he noted, are available nonprescription in Germany. In the U.S., both prescription Seldane and Hismanal carry a boxed label warning for use with certain anti-infectives, particularly ketoconazole, that likely will prevent an Rx-to-OTC switch in this country. In Germany, ketoconazole and isoconazole are available nonprescription. The safety profile of the nonsedating antihistamines was "intensively discussed" in Germany but their "OTC status was nevertheless upheld," Altherr noted. "In my opinion, this was the right decision," he added. "Limitation of the single and daily dose and the duration of administration, however, is necessary." Nicotine patches also are being considered for nonprescription status in Germany, Altherr said, because of the extensive worldwide experience with nicotine chewing gum. Because "nicotine chewing gum is already available without prescription [in many countries], other formulations such as the patch are in my opinion possible and have advantages in certain cases." Altherr said. He explained that although nicotine is "of course, a toxic substance . . . the alternative is smoking and this is definitely more harmful." Altherr urged the audience "not to relax your efforts to develop effective and safe drugs for self-medication." He suggested that "new substances should also be switched to OTC status as soon as there is enough experience of their use" and that other countries "will be able to learn from the good experience in the 'switch countries' so that further switches can be made." He pointed to the OTC status of acyclovir for a herpes cold sore indication in Germany as an example of a switch that could be adopted elsewhere. In a separate address to WFPMM, Schering-Plough International Senior Director of OTC and Consumer Products Steven Francesco reported that Schering-Plough is seeking nonprescription status for loratadine "outside the U.S." for the treatment of seasonal and perennial rhinitis. He also noted that the company is looking to broaden the nonprescription availability overseas for clotrimazole (GyneLotrimin) as a treatment for vaginal candidiasis. Clotrimazole and loratadine are both already available in the U.K. without prescription, Francesco observed. He pointed to the U.K. Medicine Control Agency's recently published list of possible switch drugs -- which includes cimetidine and famotidine for heartburn and beclomethasone drops for allergies ("The Tan Sheet" July 12, p. 1) -- as further proof that "the boundaries of self- medication are being expanded." Francesco told the group that "one cannot underestimate the value of a breakthrough product to treat an existing OTC indication" in the U.S. or abroad. However, Sudler & Henessey Executive Vice President Arthur Rosen cautioned the audience that while switches are "the engine driving the OTC business in the U.S.," restricted distribution and marketing, consumer attitudes, and government-subsidized prescription drug sales in the international marketplace can act as barriers to switch product sales. For example, in France and Switzerland, Rosen said the populace is generally satisfied with the present governments' health care reimbursement systems for prescription drugs and, consequently, there is not a great demand for Rx-to-OTC switches. In addition, while nonprescription status is becoming the norm for certain categories of drugs in Europe, it is due largely to government initiatives and not consumer demand, Rosen maintained. He added that it is difficult to create consumer demand given the international controls on nonprescription drug advertising. Rosen allowed, however, that certain European developments, including certain "national campaigns to promote self-care," were changing the market. In the U.K., Rosen reported that sales of switch products were flourishing; of the 10 top-selling nonprescription products, nine were switches -- Solpadeine, Nicorette, Benylin, Calpol, Nurofen, paracetemol (acetaminophen in the U.S.), Gaviscon, Triludan, and Sudafed. In the Netherlands, the expanding OTC venues also encourage switch product sales, Rosen said. Karl-Heinz Schonbach, director of the contract department of the German National Association of Sick Funds, predicted that the "highest potential growth [in the OTC marketplace] can be estimated as being in Germany, Italy, and the U.K." In addition, Schonbach pointed out that in most European countries "innovations in the distribution sector are unknown, quite different from in the U.S." Currently, there are fewer European venues for "low-cost distribution of pharmaceuticals" due to restricted nonprescription distribution, but Schonbach said that he believed that would change. "In Germany, some big manufacturers have started skipping wholesalers, especially in the OTC market," Schonbach said, adding that "within 10 years, mail- order drug selling will be known in Europe, too. Surely, in this future time, the value of the OTC market in Europe will be the same as in the States today."
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