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| |  Voltaren-XR, Smallest Once-daily NSAID Introduced in the U.S. SUMMIT, N.J., April 23, 1996 -- Ciba Pharmaceuticals today announced the U.S. introduction of Voltaren(R)-XR (diclofenac sodium) extended-release tablets, a new form of Voltaren(R) (diclofenac sodium) for the chronic treatment of osteoarthritis and rheumatoid arthritis that addresses the preferences of most arthritis patients for once-daily arthritis therapy and small tablet size. For most arthritis patients, Voltaren-XR relieves osteoarthritis and rheumatoid arthritis with just one 100 mg tablet/once a day. For the past 12 years, Voltaren has been the most widely prescribed drug in its class based on the number of prescriptions worldwide, said Jim Callahan, president of Ciba Pharmaceuticals. In most arthritis patients, the extended-release version provides a full day of relief from osteoarthritis or rheumatoid arthritis with just one daily 100 mg tablet. Preferred By Most Arthritis Patients A recent survey demonstrated that many arthritis patients prefer once-a-day therapy and a single small pill. The 1995 mall-intercept survey conducted in 15 geographically dispersed U.S. markets examined preferences regarding dosing schedules and pill size of approximately 300 arthritis patients taking prescription medication (data on file, Ciba). According to most patients, once-daily therapy is easy to remember, convenient, and not likely to interfere with an active lifestyle, said Joseph Papa, vice president of marketing planning for CibaGeneva. When shown Voltaren-XR and other NSAIDs, patients almost unanimously indicated a preference for one Voltaren-XR tablet over a two-pill dose of other once-daily NSAIDs, and most preferred the smaller size of Voltaren-XR. Once-Daily Therapy Voltaren-XR not only offers one-tablet, once-a-day dosing for most arthritis patients, it is also the smallest tablet of any once-daily NSAID. Double-blind clinical trials of Voltaren-XR demonstrated sustained improvement in disease severity, reduction in joint pain on motion, and reduction in number of tender and swollen joints -- including sustained reduction in duration of morning stiffness and time to walk 50 feet, said Audrey Kriegman, M.D., director, medical affairs, Ciba (data on file, Ciba). Safety And Side Effects Voltaren-XR offers the proven efficacy and safety of Voltaren plus the advantage of convenient dosing, said Dr. Kriegman. Voltaren-XR has been used outside the U.S. for more than 17 years and is one of the best selling systemic formulations of Voltaren. In four pivotal U.S. trials, Voltaren-XR was generally well tolerated, with relatively few clinically significant adverse events. The most commonly reported adverse experiences (3% or more) during three months use of Voltaren-XR are diarrhea (10.8%), abdominal pain (8.9%), dyspepsia (6.6%), nausea (4.9%), and headache (3.4%). As with other NSAIDs, the most frequent complaints relate to the gastrointestinal (GI) tract. In patients treated chronically with NSAID therapy, serious GI toxicity such as bleeding, ulceration, and perforation can occur. Elevations of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), some significant, have been reported in association with diclofenac treatment; cases of severe hepatic reactions have been reported. If patients are treated chronically, periodic monitoring of transaminases is recommended. Voltaren-XR is contraindicated in patients hypersensitive to aspirin, other NSAIDs, or diclofenac. With its convenient dosing and proven efficacy and safety, Voltaren-XR should be considered for most patients who are candidates for NSAID therapy for osteoarthritis or rheumatoid arthritis, said Dr. Kriegman. Voltaren-XR 100 mg is priced comparably with other once-daily NSAIDs and lower than the daily cost of Voltaren 75 mg twice a day (based on AWP/100 x number of tablets/day; AWP: February 1996 Medi-Span(R); NPA PlusT, IMS America, Ltd., 1996). It is available nationwide in bottles of 100 tablets. Voltaren-XR is marketed by Ciba Geneva Pharmaceuticals, Summit, New Jersey. Ciba Geneva is a marketing alliance of Ciba Pharmaceuticals of Summit, N.J., and Geneva Pharmaceuticals, Inc., of Broomfield, Colo. Both are business units of Ciba-Geigy Corporation of Tarrytown, N.Y., a wholly owned subsidiary of Ciba-Geigy Limited of Basel, Switzerland. Ciba Pharmaceuticals is dedicated to discovering, developing, manufacturing and marketing innovative pharmaceuticals that meet unmet medical needs and improve patients quality of life. Ciba Geneva is dedicated to anticipating and meeting the needs of existing and emerging customers in the U.S. healthcare market by offering high-quality branded and generic pharmaceuticals and innovative medical solutions. Ciba also manufactures and markets Cataflam(R) (diclofenac potassium) immediate-release tablets.
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