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| |  Sporanox Now Indicated to Treat Fungal Nail Disease TITUSVILLE, N.J., Oct. 18, 1995 -- SPORANOX(R) (itraconazole capsules), a medication that can produce mycological cure in the treatment of fungal nail disease, an infection suffered by one in 25 Americans, is now available for this new indication. Clinical studies show that many patients who receive a short course of daily treatment with SPORANOX experience significant visible improvement of fungal toenail infections. "Many patients have lived for years with the pain and humiliation of nails destroyed by fungal nail disease because little could be done for them," says Richard Odom, MD, clinical professor, Department of Dermatology, University of California San Francisco. "SPORANOX is the first therapy to offer these patients hope by providing a high level of efficacy in approximately one-fifth of the treatment time of current therapies." The Challenge of Treatment Until now, fungal nail disease has been difficult to treat. Few medications reach two important locations in the nail -- the nail matrix and nail bed - in adequate concentrations and for long enough durations to obliterate invading fungus. With once-daily administration (200 mg) for only three months, SPORANOX penetrates the nail plate through the matrix (where nail growth originates) and diffuses up from the nail bed by forming a store of active agent in these areas. "I had fungal nail disease for 10 years and tried nearly everything to treat it, but the condition only worsened to where I was uncomfortable standing on my feet all day at work," said Hal Turrentine, a nursing student from San Francisco, California, "What's more, until SPORANOX finally cleared my infection I wore my sandals with socks because my toenails were so embarrassing." "What we've been lacking is an effective, short-term treatment that targets the source of the infection for an extended period of time with a favorable safety profile," said Dr. Odom. "SPORANOX fulfills this need." Fungal Nail Disease Fungal nail disease is the most common nail disorder, affecting nearly 11 million Americans. It can affect toenails, fingernails or both and it usually can be caused by infectious organisms known as dermatophytes. Characteristic features of fungal nail disease include discoloration and thickening of the nail, accumulation of debris under the nail and detachment of the nail plate from the nail bed. Toenails are the primary site of infection. Fingernails are affected less frequently and involvement of both fingernails and toenails in the same patient is uncommon. Fungal nail disease can affect people of any age, gender and race. Some evidence indicates that fungal nail disease can be employment-related. Jobs that require individuals to remain on their feet for long periods of time in tight-fitting shoes, such as waiters, policemen, and construction workers, may increase the likelihood of infection. "Fungal nail disease causes patients a lot of discomfort," said Dr. Odom. "In the most severe cases, the damaged nail can separate from the nail bed, forming a reservoir for secondary infections." Safety Profile SPORANOX has a favorable safety profile and is well tolerated. In clinical trials the following adverse events led to either a temporary or a permanent discontinuation of treatment: elevated liver enzymes (4 percent), gastrointestinal disorders (4 percent), and rash (3 percent). SPORANOX should not be taken with terfenadine (Seldane(R)), astemizole (Hismanal(R)), cisapride (Propulsid(R)) or oral triazolam (Halcion(R))*. Postmarketing experiences have included reports of elevated liver enzymes and rare hepatitis. If clinical signs and symptoms consistent with liver disease develop, SPORANOX should be discontinued. SPORANOX should not be administered for the treatment of fungal nail disease to pregnant patients or to women contemplating pregnancy. Janssen Pharmaceutica SPORANOX is manufactured and marketed by Janssen Pharmaceutica, Inc., a subsidiary of Johnson & Johnson. Janssenconducts research in a wide range of medical fields including allergy, anesthesiology, cardiology, dermatology, neurology, oncology, gastroenterology, psychiatry and infectious disease and is considered a leader in antifungal research. * Seldane(R) is a registered trademark of Marion Merrell Dow, Inc.; and Halcion(R) is a registered trademark of The Upjohn Company. CONTACT: Melissa Grigorieff of Wang Associates, 212-685-1900
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