Prisyna Announces Publication of Research Demonstrating Synvazas Effect on Oral Lesion Relief

Prisyna, the oral care division of Synedgen, founded to optimize oral
health using advanced, proprietary glycomics technology, today announced
new research showing that Synvaza®, an oral rinse product, reduced
mucosal pain without anesthetic effect and improved oral function in
patients with ulcerative oral mucosal lesions. The study, “Efficacy
of a glycopolymer-based oral rinse upon pain associated with ulcerative
and erosive lesions of the oral mucosa: A within-subject pilot study,”
was published in Oral Surgery, Oral Medicine, Oral Pathology and Oral
Radiology.

The pilot study was powered to evaluate the efficacy of Synvaza in
reducing pain associated with existing erosive or ulcerative lesions of
the oral mucosa and to understand the magnitude of the effect on pain
reduction in order to power future studies. Results showed that Synvaza
significantly reduced severity in all measures of oral soreness from
baseline to 72 hours.

Twenty-five subjects with ulcerative/erosion lesions and moderate pain
were enrolled in this open label study. They were provided with a
72-hour supply of Synvaza and instructed to use as needed for 72 hours
with a minimum frequency of two times per day, swished for one minute at
each use, with the first dose used upon awakening and the last dose just
before bedtime. At the start of the study, and 24, 48 and 72 hours after
first product use, subjects completed surveys in which they documented
pain scores and oral symptoms, including mouth and throat soreness,
domain specific problems with eating, drinking, swallowing, talking,
sleeping, and general symptoms of dry mouth and mouth and throat lining
sensitivity and pain. Ratings ranged from zero, representing absence of
symptoms, to ten, representing the most severe degree of symptoms.

The overall soreness score showed a continuous decline across the four
time points and all of the oral soreness scores had a statistically
significant decrease from baseline to 72 hours. The largest domain
specific decrease from baseline to 72 hours was for oral soreness
associated with talking (67%), followed by drinking (62%), swallowing
(56%), sleeping (51%), and eating (50%). Overall soreness from baseline
to 72 hours decreased by 28%.

“The study showed reductions in mouth or throat pain, changes in dry
mouth and sensitivity of the lining of the mouth and throat to spicy,
hot or acidic foods, which may represent a meaningful improvement in
quality of life for patients,” said lead author Joel B. Epstein, DMD,
MSD. “Additionally, early pain reduction was commonly reported, with a
cumulative effect that appeared to increase with successive rinse
applications for the duration of the study, implying a potential broad
range of effect upon painful oral mucosal conditions.”

“Synvaza addresses the needs of patients who suffer from the pain of
oral lesions, which can have a substantial negative effect on their
daily routine and in more acute circumstances can be quite
debilitating,” stated Leo Pranitis, Prisyna General Manager. “We look
forward to the continued study and development of Synvaza to potentially
provide relief for patients suffering from ulcerative oral mucosal
lesions as part of our commitment to addressing a broad range of patient
oral care needs using our innovative glycomics technology.”

Disclosure: Synedgen Inc. provided funding for this research and
contributed to the protocol design, development and manuscript. Data was
analyzed and interpreted independently. The National Institutes of
Health / National Institute of Dental & Craniofacial Research supported
oral mucositis research under Grant Number: 2R44DE019740-02.

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/

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