Evoxac (cevimeline) is a medication approved by the U.S. Food and Drug Administration to treat the symptoms of dry mouth caused by Sjogren’s syndrome, a condition commonly associated with scleroderma.
How Evoxac works
In Sjogren’s syndrome, the immune system mistakenly attacks glands that produce fluids such as tears and saliva. As a result, patients often experience dry eyes and mouth, which can make it difficult for them to speak, taste food, and swallow. These patients also have an increased risk of tooth decay.
Evoxac is a type of saliva stimulant; it increases saliva secretion, which can relieve the symptoms of dry mouth and help protect teeth from decay.
Saliva secretion is controlled by the parasympathetic nervous system. It is triggered in response to a chemical messenger called acetylcholine, binding to and activating muscarinic receptors on the saliva glands.
The active ingredient of Evoxac, cevimeline, is derived from acetylcholine. It acts to directly stimulate the M3 receptors in place of acetylcholine, causing saliva to be secreted.
The medication may also be used to treat dry eyes because it can stimulate the tear glands, too.
Evoxac in clinical trials
Evoxac’s effectiveness in treating dry mouth has been demonstrated in three key placebo-controlled clinical trials.
The first one was a six-week, placebo-controlled trial that enrolled 75 patients with Sjogren’s syndrome at eight U.S. sites. It investigated the effect of 30 mg or 60 mg of Evoxac three times daily compared to a placebo.
The results, published in the medical journal JAMA Internal Medicine, demonstrated that both doses of Evoxac significantly improved the symptoms of dry mouth, increasing saliva flow. The 60 mg dose did not have any increased benefit compared to 30 mg, but was associated with more side effects. This included sweating, nausea, and shivering accompanied by a high temperature.
The second trial was a 12-week placebo-controlled trial with 197 Sjögren’s syndrome patients to evaluate the safety and effectiveness of Evoxac compared to a placebo. Patients took either a placebo or 15 mg or 30 mg of Evoxac three times daily.
Trial results, published in the journal Arthritis & Rheumatism, suggested that 30 mg of Evoxac significantly improved symptoms and saliva flow compared to placebo. The 15 mg dose was not as effective, but still improved symptoms. Evoxac also significantly improved symptoms of dry eyes.
A third trial was also a 12-week randomized, placebo-controlled study in people with Sjogren’s syndrome. With 212 participants, it confirmed that 30 mg of Evoxac taken three times daily significantly increased salivary flow compared to placebo. A 15 mg dose taken three times a day showed no significant effects compared to placebo in this trial.
The effectiveness of Exovac in treating dry eyes in Sjogren’s syndrome was investigated by researchers in Japan. The trial enrolled 60 patients to receive either a placebo or Evoxac at 20 mg or 30 mg three times a day for four weeks; they were monitored for up to an additional four weeks.
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