Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Dermatology | Ophthalmology | Rheumatology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: MGI Pharma
Approval Status: Approved February 1998
Treatment Area: Sjogren's Syndrome
Salagen Tablets (pilocarpine HCl) has been approved as a
treatment for the symptoms of dry mouth resulting from
Sjogren's Syndrome, chronic, autoimmune disease.
MGI Pharma 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, which was
maintained throughout the duration of the study. The studies also
showed 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.