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| |  SPORANOX Capsules Cleared for New 'Pulse' Dosing TITUSVILLE, N.J., Dec. 16, 1996 -- Janssen Pharmaceutica announced today that SPORANOX(R) (itraconazole) capsules, is cleared for "pulse" dosing treatment of fingernail fungus (onychomycosis due to dermatophytes tinea unguium). SPORANOX is the first oral antifungal agent to be cleared for pulse dosing. SPORANOX pulse therapy allows patients to take less drug for 67 percent fewer days than other oral antifungals, or SPORANOX continuous dosing. The unique SPORANOX pulse dosing regimen consists of a one-week pulse of 200 mg twice daily, then a three week rest period. Two SPORANOX pulses are required for fingernail fungus. Because patients take fewer capsules, the cost of pulse dosing is significantly less than continuous (daily) therapy with SPORANOX. "The advantage of the new SPORANOX pulse dose is that patients are exposed to less drug," said Richard Odom, MD, professor of clinical dermatology, interim chair, Department of Dermatology, University of California San Francisco. "Plus, patients take it for only two weeks versus six weeks for other products, therefore compliance may be improved." "I took SPORANOX pulse, and it was much more convenient because I only had to take it for one week out of the month," said Arville Wade, 64, of Walnut Creek, California. Pulse dosing is possible with SPORANOX because of its unique pharmacokinetic profile. Unlike other oral antifungals, SPORANOX remains in the nail for up to six months after the end of treatment; however, SPORANOX is undetectable in the blood stream after two weeks. Safety Profile SPORANOX should not be taken with terfenadine (Seldane(R)), astemizole (Hismanal(R)), cisapride (Propulsid(R)) due to serious cardiovascular events. SPORANOX should not be taken with oral triazolam (Halcion(R)), oral midazolam, lovastatin (Mevacor(R)) and simvastatin (Zocor(R)). Postmarketing experience across indications has 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 onychomycosis to pregnant patients or to women contemplating pregnancy. SPORANOX is well tolerated. In fingernail clinical trial experience, the following adverse events led to either a temporary or permanent discontinuation of treatment: rash/pruritus (3%) and hypertriglyceridemia (3%). SPORANOX Success When it was cleared for the treatment of toenail fungus in October 1995, SPORANOX revolutionized the treatment of fungal nail disease. SPORANOX gave physicians efficacy in a short treatment duration. SPORANOX is currently the number one oral antifungal agent in terms of worldwide sales, across indications, based on data compiled by International Marketing Service. "SPORANOX has more than 57 million patient days of experience in the United States. We anticipate continued success for SPORANOX with our innovative pulse dosing that involves administration of less drug for a shorter treatment time at a greatly reduced cost," said Bruce Given, MD, Group Vice President, Sales and Marketing, Research and Development at Janssen Pharmaceutica. Fungal Nail Disease Fungal nail disease affects 10-12 million Americans. It can affect toenails, fingernails or both. Characteristic features include hard, thick, yellow nails; accumulation of debris under the nail; detachment of the nail plate from the nail bed; nail deformation and pain. Janssen Pharmaceutica 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 Hoechst Marion Roussel, Inc.; Halcion(R) is a registered trademark of Pharmacia & Upjohn; Mevacor(R) and Zocor(R) are registered trademarks of Merck & Co., Inc.
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