Prisyna Announces Publication of Research Demonstrating Synvaza’s Effect on Oral Lesion Relief
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.
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/
MacDougall Biomedical Communications
Amanda Houlihan, 781-235-3060