Prisyna Receives FDA 510(k) Clearance for MoisynTM Product Line to Treat Dry Mouth

CLAREMONT, Calif.--(BUSINESS WIRE)-- Prisyna, the oral care division of Synedgen, founded to optimize oral health using advanced, proprietary glycomics technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its family of Moisyn™ products designed to treat xerostomia.

Xerostomia (also known as dry mouth, or dry mouth syndrome) is an unpleasant and challenging oral health condition that occurs when there is a decrease in the presence of saliva. Dry mouth affects a large percentage of the adult population, and as much as half of the elderly population in the United States. The symptoms of dry mouth significantly impact patient quality of life and often cause difficulty in chewing, swallowing and speaking, and can result in dry, thick oral mucus, painful oral tissues, bad breath, and sleep disturbance.

“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 healthcare community through our glycomics technology.”

In a clinical study where patients used Moisyn up to four times daily, statistically significant reductions occurred in symptoms associated with dryness, ability to eat and swallow, mouth sensation and taste. Key symptoms treated by Moisyn included 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.i

“Xerostomia, or dry mouth, is a challenging and frustrating oral health care issue that affects up to 20 percent of the adult population and nearly 50 percent of the elderly population in the U.S.,” said Joel Epstein, DMD, MSD, and 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.”

About Xerostomia (Dry Mouth)

Xerostomia, or dry mouth, causes dryness in the oral cavity, most commonly the tongue and roof of the mouth. Typically, it is identified by a reduction or absence of oral saliva and can be brought on by a variety of conditions, including aging. Over 1000 prescription and non-prescription medications, including drugs for treating anxiety, depression, high blood pressure, allergies, and cancer are known to alter the production of saliva and cause dry mouth as a side effect.

Common problems stemming from dry mouth include tooth decay, disturbed sleep, dry throat, burning sensation in the throat, gum disease, oral infections, taste change, and difficulty speaking and swallowing.

About Prisyna

Prisyna, the oral healthcare division of Synedgen, is developing and commercializing a new class of oral health care products based on glycomics, a revolutionary approach using natural glycopolymers to target the mucosal interface. Prisyna uses this unique technology to develop oral health care products that clean the mouth, reduce pain and irritation on sensitive mucosal surfaces and improve overall oral health. Prisyna is building a family of environmentally safe products using cutting edge science to promote healthy teeth, gums and oral surfaces. http://www.prisyna.com/

i Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Jan;123(1):76-83. doi: 10.1016/j.oooo.2016.09.008. Epub 2016 Sep 28.

Contacts

MacDougall Biomedical Communications
Amanda Houlihan, 781-235-3060
ahoulihan@macbiocom.com

 

 
 

Source: Prisyna

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