Prisyna receives FDA clearance for Moisyn xerostomia products
Prisyna has received 510(k) clearance from the US Food and Drug Administration to market its family of Moisyn xerostomia products.
Prisyna, the oral care division of Synedgen, announced on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration to market its family of Moisyn products designed to treat xerostomia.
“With the FDA clearance for Moisyn products, patients will have access to a new treatment that can alleviate the symptoms of dry mouth and improve their oral health,” said Leo Pranitis, general manager of Prisyna. “We are now able to offer patients an innovative new option for treating xerostomia using the first glycomics targeted therapy that has been shown in a clinical study to reduce pain and increase comfort. Data from this clinical study further validates our vision to bring better outcomes to the oral health-care community through our glycomics technology.”
According to the manufacturer, statistically significant reductions occurred in symptoms associated with dryness, ability to eat and swallow, mouth sensation, and taste in a clinical study where patients used Moisyn up to four times daily. Patients experienced reduced mouth pain, improved ability to sleep, and improved sense of taste. As a result of treatment with Moisyn, patients in the study reported a reduction in food becoming lodged in the throat due to dryness and a change in the saliva thickness, positively affecting food choices as well as the quality of sleep. (1)
“Xerostomia, or dry mouth, is a challenging and frustrating oral health care issue that affects up to 20% of the adult population and nearly 50% of the elderly population in the US,” said Joel Epstein, DMD, MSD, principal investigator of a Moisyn clinical study. “Many of these patients have medical conditions such as autoimmune diseases or diabetes that can cause dry mouth, and dry mouth may be seen in people being treated for diseases such as cancer or as a side effect of certain medications. For patients living with xerostomia, Moisyn can relieve the symptoms of dry mouth and could be an important contribution to overall oral health.”
1. Epstein JB, Villines DC, Singh M, Papas A. Management of dry mouth: assessment of oral symptoms after use of a polysaccharide-based oral rinse. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;123(1):76-83. doi:10.1016/j.oooo.2016.09.008.