Prisyna Announces Oral Clinical Study Results
March 5, 2016 Claremont CA—Prisyna today announces the first results from a 57 patient clinical study evaluating Moisyn Oral Rinse to help alleviate the symptoms associated with xerostomia.
Xerostomia, or dry mouth, is a painful and frustrating oral health care issue that affects up to 20 percent of the adult population and nearly 50 percent of the elderly in the US today. The complications of dry mouth can be caused by more than 1,800 commonly used medications, radiation therapy for head and neck cancer, Sjogren’s syndrome and other conditions. Dry mouth significantly impacts patient quality of life, induces difficulty chewing, swallowing and speaking, dried thick oral mucus, painful dry oral tissues, bad breath, and sleep disturbance.
The IRB approved study was conducted at two sites; Cedars-Sinai in Los Angeles and Tufts University in Boston. The study design was a pre-test post-test prospective cohort within-subject study on recruits with significant dry mouth symptoms requiring medication. Participants included Sjogren’s patients and individuals on medications for cholesterol, anti-depressants, blood pressure, pain control and antacids. Participants used Moisyn rinse daily with the optional Moisyn spray for seven days, and then self-reported changes in their oral symptoms and function. Nearly all patients had been using some other form of treatment to control the symptoms of their xerostomia.
After one week of use of Moisyn, statistically significant reductions occurred in 15 of the 33 symptoms regarding issues with dryness, saliva, mouth sensation and taste and 84% of the participants noted they would use Moisyn again. The top three symptom relieving effects reported related to the dry, sticky mucus often found in xerostomia patients: 1) food getting stuck in the throat due to dryness, saliva thickness affecting food choices and 3) saliva thickness affecting sleep. Other important statistically important reductions in symptoms after Moisyn use included reducing 1) problems with dry mouth affecting ability to sleep, 2) reducing mouth pain, 3) pain causes difficulty in sleeping and 4) the chosen foods to eat are altered based on taste changes.
See Management of dry mouth: assessment of oral symptoms after use of a polysaccharide-based oral rinse in the journal of Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology (2017) Volume 123, Issue 1, Pages 76–83 for results.
“The results of this clinical study represent an important milestone for Prisyna—the observations we have seen in the laboratory and in in vivo studies have translated well to humans. We are very pleased to see that Moisyn provides significant relief to patients with xerostomia and related oral conditions,” stated Prisyna team leader Shenda Baker.
Written comments from participants echoed the primary study results. “The product reduced my over night mouth dryness by 50%”; “Great tasting product with soothing relief of dry mouth”; and “This is a product I would use and suggest to others for relief of dry mouth”.
The company plans more studies to study the benefits of Moisyn and is completing regulatory requirements for FDA clearance.