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EVOXAC Efficacy And Clinical Studies

EVOXAC is a cholinergic agonist which binds to muscarinic receptors and significantly improves salivary flow for patients suffering from dry mouth associated with Sjögren's syndrome.9 Clinical trials have shown EVOXAC to be both safe and effective.10-12

Clinical Studies11

A 6-week, randomized, double blind, placebo-controlled study (Study C) was conducted in 75 patients (10 men, 65 women) with a mean age of 53.6 years (range 33-75). The racial distribution was Caucasian 92%, Black 1% and other 7%. The effects of cevimeline at 30 mg tid (90 mg/day) and 60 mg tid (180 mg/day) were compared to those of placebo. Patients were evaluated by a measure called global improvement, which is defined as a response of “better” to the question, “Please rate the overall condition of your dry mouth now compared with how you felt before starting treatment in this study.” Patients also had the option of selecting “worse” or “no change” as answers. Seventy-six percent of the patients in the 30 mg tid group reported a global improvement in their dry-mouth symptoms compared to 35% of the patients in the placebo group. This difference was statistically significant at p=0.0043. There was no evidence that patients in the 60 mg tid group had better global evaluation scores than the patients in the 30 mg tid group.

A 12-week, randomized, double-blind, placebo-controlled study (Study A) was conducted in 197 patients (10 men, 187 women) with a mean age of 54.5 years (range 23-74). The racial distribution was Caucasian 91.4%, Black 3% and other 5.6%. The effects of cevimeline at 15 mg tid (45 mg/day) and 30 mg tid (90 mg/day) were compared to those of placebo. Statistically significant global improvement in the symptoms of dry mouth (p=0.0004) was seen for the 30 mg tid group compared to placebo, but not for the 15 mg group compared to placebo. Salivary flow showed statistically significant increases at both doses of cevimeline during the study compared to placebo.

A second 12-week, randomized, double-blind, placebo-controlled study (Study B) was conducted in 212 patients (11 men, 201 women) with a mean age of 55.3 years (range 24-75). The racial distribution was Caucasian 88.7%, Black 1.9% and other 9.4%. The effects of cevimeline at 15 mg tid (45 mg/day) and 30 mg tid (90 mg/day) were compared to those of placebo. No statistically significant differences were noted in the patient global evaluations. However, there was a higher placebo response rate in this study compared to the aforementioned studies. The 30 mg tid group showed a statistically significant increase in salivary flow from predose to post-dose compared to placebo (p=0.0017).

EVOXAC Efficacy Measured by Objective and Patient-Assessed Endpoints

  • The primary endpoint was global improvement in dry mouth
    • Patients rated their overall condition compared with before the study as "better," "no change," or "worse"10-12
    • Significant improvement in the symptoms of dry mouth was observed in 2 of 3 clinical trials vs. placebo. However, there was a higher placebo response rate in one 12-week study vs. the study arm.
  • The secondary endpoint was improvement in salivary flow, as measured by mean change in flow rate*10-12
*
Total salivary flow was measured at each visit prior to dosing, at a minimum of 90 minutes after dosing. Patients expectorated saliva into a collection tube for 15 minutes. The tube was then sealed and weighed. Since the specific gravity of saliva is approximately 1, the flow was recorded in mL/min.10-12

Patients Reported Significant Global Improvement* in Dry Mouth10-12

Patients reporting dry mouth as 'better'
  • NS = Not Significant
  • 53% to 76% of patients reported their dry-mouth symptoms as "better"10-12*†
  • Patients also reported significant improvement (P≤0.05) in subjective secondary endpoints (in the individual symptoms of dry mouth) in one or more placebo-controlled trials
    • Symptoms included ability to chew and swallow food, dryness of tongue, and ability to speak without drinking10-12‡
*
Patients self-reported overall feeling of dry mouth (primary efficacy endpoint) compared with before the study as "better," "no change," or "worse" at study endpoint.
†
Studies A and B were 12-week, placebo-controlled trials. Study C was a 6-week, placebo-controlled trial. Significant improvement in the symptoms of dry mouth was observed in 2 of 3 clinical trials vs. placebo. However, there was a higher placebo response rate in Study B vs. the study arm
‡
Ability to chew and swallow food, change from pre-dose to post-dose at final visit and week 6; dryness of tongue, change from baseline to week 6; and ability to speak without drinking, change from baseline to endpoint. Statistical significance was not observed consistently for every endpoint at each point of measurement across all studies.

Salivary Flow was Significantly Improved10-12

Changes in post-dose salivary flow
*
Total salivary flow was measured at each visit prior to dosing and at a minimum of 90 minutes after dosing.
†
Change from baseline through study endpoint.
‡
Studies A and B were 12-week, placebo-controlled trials. Study C was a 6-week, placebo-controlled trial.

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