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TOPICAL ERYTHROMYCIN, RETIN-A FOR ACNE ARE LOGICAL Rx-TO-OTC SWITCH CANDIDATES, DERMATOLOGIST TELLS NDMA; ANTIFUNGAL/HYDROCORTISONE OTC COMBO SUGGESTED

Executive Summary

Logical OTC switches among currently available topical prescription drugs include two anti-acne agents, a herpes drug and a genital warts treatment, dermatologist William Rosenberg, MD, University of Tennessee College of Medicine, suggested at the Nonprescription Drug Manufacturers Association's Rx-to-OTC switch symposium in Washington on Sept. 15. Rosenberg singled out topical erythromycin and J&J's Retin-A (tretinoin) as potential OTC acne treatments, Burroughs Wellcome's Zovirax (acyclovir) as an OTC candidate for treating cold sores, and Oclassen's Condylox (podofilox .5%) for potential OTC availability for treating genital warts. The concern that OTC availability of topical erythromycin could lead to the expansion of resistant microbes to the antibiotic in the general population was discounted by Rosenberg. Such objections, Rosenberg asserted, are inconsistent with the information dermatologists receive from the medical literature and from product labeling. "There is no suggestion of environmental protection to those of us writing prescriptions," he said. "At no time has it ever been suggested to the practicing dermatologist that he restrain his use of this agent in order to retard the development of drug resistance. Such statements are of course made with other drugs." Topical erythromycin is "widely prescribed" for acne, is very safe and "it is effective, proven beyond doubt," Rosenberg said. In addition, he noted that "the directions for use can be understood" and "young people who get acne are by definition capable of diagnosing it." The net result of topical erythromycin's prescription-only status, Rosenberg suggested, is unequal care -- "young people who can afford to go to a physician get a prescription for topical erythromycin almost universally; young people who are obliged to treat themselves from the drug shelf counter from the supermarket or drug store because their family does not have the means to send them to a physician are denied this." Consequently, he added, "the onus of protecting the environment falls on the poorer children." Topical erythromycin has come up as a potential OTC switch candidate in the past. FDA's Office of Drug Evaluation II Director James Bilstad suggested at a public meeting in 1989 that topical erythromycin looked like a good candidate for OTC availability. A number of companies currently market prescription topical erythromycin products for treating acne, including Ortho, Herbert Labs, Westwood-Squibb, and Medicis. Regarding Retin A, Rosenberg said he did not "see any reason why it should not be available OTC for acne." In addition, he suggested that making podofilox .5% topical solution available as an OTC treatment for genital warts would make sense from a health policy perspective given the product's low cost relative to other treatments, such as lasers or recombinant alpha interferon. He pointed out that podofilox, while prescription-only, is already designed for home use. "Anybody who has had genital warts will get them again and the diagnosis is not an issue for most of these patients," he said, adding that podofilox "is entirely appropriate ...to be over-the-counter." Rosenberg based his views on topical acyclovir's potential as an OTC treatment for fever blisters on current physician prescribing patterns for the prescription antiviral. "I want you all to know that the doctors who prescribe [Zovirax topical] do not prescribe it [for its labeled use] primary genital herpes simplex," he stated. "Patients want to know what can [be done] for fever blisters and many physicians, I included, will say here is an ointment [that] if you start using it at the very first sign of burning and stinging, it might help [and] it certainly won't hurt." Schering-Plough's combination antifungal/corticosteroid topical agent Lotrisone (clotrimazole/beta-methasone) was also suggested by Rosenberg as a potential switch candidate based on how primary care physicians generally use the product for relatively mild skin irritations that could be fungus-related. "It might be a fungal infections, it might be a little bit of excema ...it won't do any harm to treat [the patient] for both at once," he said. "From a decision-tree analysis point-of-view, from a theoretical point-of-view of how we actually have to manage illnesses,...what is so wonderful about making a diagnosis on the first leg anyway?" Rosenberg hypothesized. "What is so wrong about a product which is not bad for two of the leading causes of a symptom and thinking about the [cause of illness] if the product doesn't work?" Rosenberg further suggested that Rx-to-OTC switches should be considered within the context of controlling medical care costs. Commenting on Rosenberg's Lotrisone suggestion at NDMA's legal conference on Sept. 16, Clairol VP-R&D Edward Marlowe said that betamethasone may not be "a viable candidate" for an Rx-to-OTC switch given the "untoward reactions" associated with fluorinated steroids. Marlowe suggested, instead, that an antifungal combined with hydrocortisone "could be a very interesting" OTC product representing a potentially "big opportunity" for industry. He explained that "there is a good medical rationale for the ingredients: one is anti-inflammatory and one is anti-fungal. There is a target population. We can show through clinical tests the contribution of each ingredient. Safety testing is relatively easy to perform; and we can certainly label this for the dual conditions." Allergist Leonard Bernstein, MD, presented what he called "an analog scale" of currently available prescription medications used in his field that have generated interest as potential OTC switch candidates. On a one-to-ten scale (with ten being a definite OTC), Bernstein rated sedating H[1] antagonists (9), Fisons' cromolyn sodium (8), and topical corticosteroids (6) as the most likely candidates for OTC availability. However, he suggested that the therapeutic-dose theophylline (2), selective beta-2 agonists (3) and Boehringer-Ingelheim's Atrovent (ipatropium), with a three rating, were very unlikely switch candidates. Bernstein noted that he down-graded nonsedating antihistamines as switch candidates after the relabeling of Marion Merrell Dow's Seldane and J&J's Hismanal in July but that he has become more optimistic after seeing new adverse reaction data from MMD (see related item, T&G- 2). Bernstein, a professor at the University of Cincinnati Medical Center and the current chairman of FDA's Pulmonary-Allergy Drugs Advisory Committee, said he was "very optimistic" about an Rx-to- OTC switch for cromolyn (Fisons' Intal, Opticrom) given the drug's safety profile. However, he suggested that a switch will "require a lot more education in patients than some other drugs." Bernstein believes that topical corticosteroids also "will make it" to OTC status. "I think the only issue is whether or not the absorption you get from long-term use of these drugs will cause osteoporosis and cataracts and...I think that has to be resolved." Sudler & Hennessey Senior VP and Medical Director Jerome Ehrlich, MD, differentiated between what he called "traditional" Rx-to-OTC switch candidates and a new category of switches that may follow from FDA's rationale in approving Ortho's Monistat and Schering-Plough's Gyne-Lotrimin for OTC treatment of recurring vaginal fungal infections. In the "traditional" switch category, Ehrlich included H-2 antagonists for treating heartburn; antiemetics, such as promethazine (AHP's Phenergan) and trimethobenzamide (SmithKline Beecham's Tigan); currently available prescription nonsteroidal anti-inflammatories; topical analgesics, such as ibuprofen, diclofenac, and piroxicam, now available in Europe; and muscle relaxants, such as cyclobenzaprine (Merck's Flexeril), orphenadrine (3M's Norflex), chlorzoxaxone (McNeil's Paraflex), carisoprodol (Wallace Labs' Soma), and methocarbamol (Robins' Robaxin). Ehrlich suggested a wide-ranging group of prescription products for recurrent medical problems that he maintained could be allowed to go OTC assuming that patients would receive an initial diagnosis from a physician. Included in his list of potential OTCs were the antifungals clotrimazole and nystatin for oral candidiasis, other antifungals for vaginal yeast infections, contraceptives such as diaphragms and cervical caps, spironolactone (Searle's Aldactone) for pre-menstrual edema; anti- infectives for recurring urinary tract infections, non-systemic anti-cholesterol agents, sublingual medications for angina, and Hoechst-Roussel's Trental (pentoxifylline) for intermittent claudication.
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