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| |  SPORANOX Sets Records For Treatment of Toenail Fungus TITUSVILLE, N.J., May 13, 1996 -- Janssen Pharmaceutica announced today that six months after its availability for treatment of toenail fungus, SPORANOX(R) (itraconazole capsules) is the most prescribed antifungal agent for this disfiguring condition. SPORANOX is the first advance in the treatment of toenail fungus (onychomycosis due to dermatophytes) in 35 years. The availability of SPORANOX has revolutionized the treatment of fungal nail disease by giving physicians a high level of efficacy in a much shorter treatment duration than previous therapies. Since SPORANOX was first made available in the United States, it has been prescribed for nearly 34 million patient days. "Before SPORANOX became available, many doctors did not treat toenail fungus because available therapies were not as effective. Now we have an option for our patients to fight the embarrassment, disfigurement and the physical pain of toenail fungus," said David Kaplan, MD, University of Missouri, Kansas City School of Medicine. Fungal nail disease affects 10-12 million Americans. It can affect toenails, fingernails or both. Characteristic features of toenail fungus include thick, yellow or brittle nails; accumulation of debris under the nail or detachment of the nail from the nail bed. Clinical studies show that many patients who receive a short, three-month course of treatment with SPORANOX experience significant visible improvement of fungal toenail infections. "The response to our print and television advertising campaigns has been unprecedented. Half a million sufferers have called our toll-free number [1-800-NAILS-90] to learn more about toenail fungus and its treatment," said Tom Middleton, Director of Mycology at Janssen. "I had fungal nail disease for ten years," said Petra Turner, a toenail fungus sufferer from Pensacola, Florida. "I tried everything on the drugstore shelf before my doctor suggested that I start treatment with SPORANOX. After a few months, my nail became less thick -- and a few months later the nail looked completely clear." 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 toenail fungus to pregnant patients or to women contemplating pregnancy. SPORANOX is manufactured and marketed by Janssen Pharmaceutica Inc., Janssen conducts 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. ** Please see full prescribing information on SPORANOX including box warning.
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