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Salagen Indication Extended To Dry Mouth In Sjogren's Syndrome MINNEAPOLIS, MN -- February 17, 1998 -- The United States Food and Drug Administration has granted marketing clearance to MGI Pharma, Inc.’s Salagen(R) Tablets (pilocarpine HCl) as a treatment for the symptoms of dry mouth resulting from Sjogren's syndrome, a chronic, autoimmune disease. The company conducted two Phase III human clinical studies, involving 629 patients, to determine the ability of Salagen Tablets to provide relief for the symptoms of dry mouth caused by Sjogren's syndrome. Study results showed significant increases in salivary flow following the first dose of Salagen Tablets, which was maintained throughout the duration (12 weeks) of the study. The studies also showed an improvement in overall dry mouth conditions, as well as specific symptoms, including: severity of dry mouth and mouth discomfort; the ability to speak, sleep and swallow food without drinking; and a decreased use of saliva substitutes. The most common side effects related to the drug were sweating, urinary frequency, chills and flushing. In 1994, the FDA granted approval to market Salagen Tablets in the U.S. as a treatment for radiation-induced dry mouth in head and neck cancer patients. Subsequently, the product has also been approved for marketing in the United Kingdom, Ireland, Greece, Hungary, The Netherlands, Sweden, Germany, Italy, Luxembourg, Austria, Spain, Portugal and the Czech Republic for the radiation indication. In Canada and Israel, the product has been approved for both the radiation-induced indication and the Sjogren's syndrome indication. Sjogren's syndrome is a chronic, inflammatory, autoimmune disease that gradually damages the moisture-producing glands, such as the salivary glands, causing patients to suffer significantly from the resulting dryness. Symptoms of the disease can vary depending upon which moisture-producing glands are affected and to what degree the glands are damaged. As a primary condition, Sjogren's syndrome affects approximately 200,000 people in the U.S., most commonly women. Sjogren's syndrome can also occur secondarily to other autoimmune diseases, particularly rheumatoid arthritis, raising the number of people in the U.S. who may suffer from some form of Sjogren's syndrome to about one million. The U.S. Public Health Service's office on Women's Health lists Sjogren's syndrome, along with other autoimmune diseases, as an important and neglected health issue affecting American women. Taken together as a class of illnesses, autoimmune diseases are the fourth leading cause of disability in women, with an annual cost to the nation of an estimated $86 billion US. More information on: Salagen(R), MGI Pharma, Inc. E-mail this page to a friend or colleague! To print, use this version