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

Approval Status:

Approved January 2000

Specific Treatments:

Indicated for the symptoms of dry mouth in patients with Sjogren's Syndrome

Therapeutic Areas

Find Related Trials for The Following Conditions

General Information

Sjogren's Syndrome is an autoimmune disorder in which the body's immune system mistakes its own moisture-producing glands as foreign and, in turn, attacks and destroys these glands, resulting in the symptoms of dry eyes and mouth, among others. 50% of Sjogren's Syndrome patients have secondary Sjogren's Syndrome, which, in addition to the above symptoms, is also associated with a disease affecting the body's connective tissue.

Two to Four million Americans may have Sjogren's Syndrome, although many of these cases go undiagnosed. 90% of patients diagnosed with the disorder are women. This incurable autoimmune disorder may be treated symptomatically. However, some of the more severe symptoms and effects on the body's organs may remain untreatable.

The active ingredient in Evoxac is cevimeline hydrochloride, a cholinergic agonist which increases secretion of the salivary and sweat glands that Sjogren's Syndrome destroys. The drug decreases dry mouth and other symptoms of Sjogren's Syndrome.

Clinical Results

Several placebo-controlled studies were conducted to examine the effectiveness of Evoxac on dry mouth symptoms in Sjogren's Syndrome patients. In all of the studies, the increase of salivary flow was statistically significant, no matter which dosage the patient was given: 15mg, 30mg, or 60mg. Patients receiving 30mg and 60mg of the drug were significantly more likely to indicate "global improvement" to their dry mouth condition (determined by a "better" response rather than a "worse" or "no change" response when asked about the condition of their dry mouth as compared to before taking the drug) after taking the drug, when compared to a placebo. There was no detected difference between global improvement of patients taking the 30mg and patients taking the 60mg dosages. However, while global improvement was significant for those taking 30mg compared to a placebo, there was no significant difference between global improvement scores of patients taking 15mg and patients taking a placebo, despite the fact that there was significant salivary flow increases even for the 15mg dose.

Side Effects

General side effects may include the following:

  • Headache
  • Visual disturbance
  • Lacrimation
  • Sweating
  • Respiratory distress
  • Gastrointestinal spasm
  • Nausea
  • Vomiting
  • Diarrhea
  • Atrioventricular block
  • Tachycardia
  • Bradycardia
  • Hypotension
  • Hypertension
  • Shock
  • Mental confusion
  • Cardiac arrhythmia
  • Tremors

Since the active ingredient, cevimeline, may cause visual disturbances, especially at night, patients should exercise caution when driving.

The drug may also cause excessive sweating which could lead to dehydration. Patients should be encouraged to drink extra water to prevent dehydration.

Drug Interactions:

  • There is a possibility of conduction disturbances when cevimeline is administered to patients taking beta adrenergic antagonists.
  • Additive effects can be expected when drugs with parasympathomimetic effects are administered concurrently with cevimeline.
  • Cevimeline might interfere with desirable antimuscarinic effects of drugs used concomitantly.

The effects of this drug on pregnant women are not known. Cevimeline should be used during pregnancy only if the potential benefit of the drug justifies the potential risk to the fetus.

There have not been sufficient studies done on pediatric use to determine safety and effectiveness. Similarly, although geriatric patients were amongst those tested in clinical trials, there have not been sufficient studies to determine any specific effects on the geriatric patient. Extra precaution should be taken when giving this drug to elderly patients.

Mechanism of Action

Cevimeline is a cholinergic agonist which bonds to muscarinic receptors. Muscarinic agonists in sufficient dosage can increase secretion of the exocrine glands, such as salivary and sweat glands and increase tone of the smooth muscle tissue in the gastrointestinal and urinary tracts. (FDA Label)

The drug is absorbed rapidly in approximately 1.5 to 2 hours. Absorption rate decreased when administered with food.

Additional Information

The Sjogren's Syndrome Foundation provides valuable information about Sjogren's Syndrome including research, educational opportunities, and patient resources. For more information, visit their web site at www.sjogrens.com or call 1-800-475-6473.