Salagen Tablets

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved February 1998

Specific Treatments:

Sjogren's Syndrome

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General Information

Salagen Tablets (pilocarpine HCl) has been approved as a treatment for the symptoms of dry mouth resulting from Sjogren's Syndrome, chronic, autoimmune disease.

Clinical Results

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.