Published results from two clinical research studies demonstrate the beneficial effects of MAXISAL®. The Company also has an issued US patent regarding MAXISAL®.  The abstract from each of these publications and a summary of the patent are provided below.

Patent 


U.S. PATENT NO: 6,656,920 B2
ISSUE DATE: DECEMBER 2, 2003
TERMINATION DATE: APRIL 18, 2023

 


PUBLICATIONS: 

 

TITLE: Use of Orally Administered Anhydrous Crystalline Maltose for Relief of Dry Mouth.

 

ABSTRACT:

Objectives: To examine the safety and efficacy of anhydrous crystalline maltose (ACM) for treatment of dry mouth.

Design: ACM was delivered orally as a 200-mg lozenge given three times daily over a 12-week (study Alpha) or 24-week (study omega) period to a total of 22 and 97 subjects, respectively. All participants had prominent complaints of persistent dry mouth associated with primary Sjogren's syndrome. Patients were examined every 4 weeks in study Alpha and every 6 weeks in study Omega.

Settings: Patients were seen in outpatient clinics at a total of 33 sites within the United States.

Outcome measures: Unstimulated whole saliva output, a measure of basal salivary gland function, was determined at each visit. Symptoms associated with oral and ocular dryness were assessed at the same time with the use of 100-mm visual analogue scales. Safety was assessed by physical examination and laboratory studies.

Results: During these clinical trials, a majority of subjects demonstrated an increase in unstimulated whole saliva output and the treatment exhibited an excellent safety profile. The ACM treatment in study Omega led to significant improvement in several subjective measures of oral and ocular comfort.

Conclusions: In these two studies, ACM lozenges administered three times daily for 12 or 24 weeks improved salivary output and decreased complaints of dry mouth and eyes. Side effects were minimal, and treatment was without significant adverse events. This safe and simple intervention may provide clinical benefit to individuals with distressing dry mouth symptoms.

 

 

TITLE: A Third Study on the Use of Orally Administered Anhydrous Crystalline Maltose for Relief of Dry Mouth in Primary Sjogren's Syndrome.

 

ABSTRACT:

Objectives: To examine the safety and efficacy of anhydrous crystalline maltose for treatment of dry mouth and other symptoms of dryness in patients with primary Sjogren's syndrome.

Design: ACM was delivered orally as a 200-mg lozenge given three times daily over a 24-week to a total of 100 subjects. All participants had prominent complaints of persistent dry mouth associated with primary Sjogren's syndrome. Patients were examined at baseline and every 6 weeks of treatment.

Settings: Patients were seen in outpatient clinics at a total of 27 sites within the United States.

Outcome measures: Unstimulated whole saliva output, a measure of basal salivary gland function, was determined at each visit. Symptoms associated with oral and ocular dryness were assessed at the same time with the use of 100-mm visual analogue scales. Safety was assessed by physical examination and laboratory studies.

Results: During this clinical trial, a majority of evaluable subjects (39/76) demonstrated an increase in unstimulated whole saliva output, and the treatment exhibited an excellent safety profile. The anhydrous crystalline maltose treatment led to significant improvement in several subjective measures of oral and ocular comfort.

Conclusions: In this study, anhydrous crystalline maltose lozenges administered three times daily for 24 weeks improved salivary output and decreased complaints of dry mouth and eyes in patients with primary Sjogren's syndrome. Side-effects were minimal, and treatment was without significant adverse events. These results are similar to the benefits observed in two prior studies reported by the authors. This safe and simple intervention appears to provide clinical benefit to primary Sjogren's syndrome patients with dry mouth symptoms.

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