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| |  Skelid Now Available In U.S. For Paget's Disease of Bone NEW YORK, May 28, 1997 -- A new oral medication for the treatment of Paget's disease of bone, an often undiagnosed but potentially painful and debilitating disease, is now available from Sanofi. Recently cleared for marketing by the U.S. Food and Drug Administration (FDA), Skelid(R) (tiludronate disodium) is now available by prescription in pharmacies. Skelid is indicated for treatment of Paget's disease of bone, a disease of the aging population. Paget's disease is a chronic disorder characterized by an excessive rate of bone remodeling, resulting in the formation of disorganized, enlarged and weakened bone structure. In advanced cases, Paget's disease typically results in enlarged and deformed bones in one or more regions of the skeleton such as an enlarged skull, bowing of a limb, or curvature of the spine. Skelid, a new bisphosphonate, is administered once a day, either in the morning or at night, and is given in a three-month dosage regimen, rather than the six-month regimen normally employed for other currently marketed oral bisphosphonates. Studies of Skelid indicated that it can control the abnormal bone growth of Paget's disease without interfering with the normal process of bone formation, as indicated by the mineralization rate, bone remodeling and bone turnover. Bisphosphonates may cause upper gastrointestinal disorders, such as dysphagia, esophagitis, esophageal ulcer, and gastric ulcer. The most common gastrointestinal adverse events with Skelid were nausea, diarrhea, and dyspepsia. Second in prevalence only to osteoporosis as a bone disease, Paget's disease affects an estimated three-to-four percent of the U.S. population over 50 years of age, and is slightly more common in men than in women. Bone pain, which may occur in any bone affected by Paget's disease, is the most common symptom, though many patients with early stages of disease or milder cases may be without symptoms. Usually, Paget's disease is localized to a particular bone or area of the body. Headaches and hearing loss may occur when Paget's disease affects the skull. Pressure on nerves may also occur when the skull or spine is affected. Sometimes the patient's symptoms are confused with arthritis or other disorders Bones affected with Paget's disease have a characteristic appearance on X-rays. Sometimes, the patient's doctor is alerted to the possibility of Paget's disease when a routine blood test reveals an elevated level of alkaline phosphatase. In such cases, more specific tests may be done. There appears to be a familial factor for Paget's disease, though there is no conclusive evidence that the disease is hereditary. After the age of 40, siblings and children of someone with Paget's disease may wish to have a standard alkaline phosphatase blood test every two or three years. Skelid for the treatment of Paget's disease was discovered and developed by Sanofi, the global healthcare company based in Paris, France. Skelid is being marketed in the U.S. by Sanofi Pharmaceuticals, Inc., the U.S. pharmaceutical division of Sanofi. Persons wishing additional information on Paget's disease should speak with their physician. Additional information on Paget's disease is available from The Paget Foundation for Paget's Disease of Bone and Related Disorders, 1-800-23-PAGET.
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