Synedgen secures FDA 510(k) approval for synvaza oral wound rinse

Synedgen has received the US Food and Drug Administration (FDA) 510(k) approval to market its Synvaza Mouth Sore and Wound Rinse over-the-counter (OTC).

Synvaza is part of the company’s oral health care business unit Prisyna, which already comprise Moisyn and Moisyn Mist for dry mouth, along with Synedent and Synedent FLX oral rinses.

Synedgen president and chief executive officer Shenda Baker said: “The Agency’s clearance of Synvaza provides a new and effective treatment option that helps manage pain while promoting healing for patients who suffer from painful ulcers and mouth sores of the oral mucosa.

“Synvaza also provides an innovative solution for patients with many types of oral wounds, including traumatic ulcers and surgical injuries. With Prisyna’s multiple offerings, Synedgen is uniquely positioned to improve oral health across multiple patient segments.”

Synvaza formulation provides moist wound environment to facilitate its healing

Synvaza is an oral wound rinse formulated with ChitoTek, mucoadhesive, hygroscopic biopolymers, which is said to form a protective barrier around oral wounds, in order to prevent irritation and help in managing pain.

The new product formulation is said to provide a moist wound environment, which would be optimal for wound healing, and has decreased pain related to ulcerative oral lesions in a clinical study.

In addition, the new oral wound rinse is also reported to have decreased oral soreness related to drinking, swallowing, eating, talking, and sleeping, and relieved pain in patients with aphthous stomatitis, oral lichen planus, and chronic graft versus host disease.

The company said that its Prisyna’s oral care portfolio is manufactured using advanced ChitoTek technology, developed by leveraging its unique glycochemistry platform, which is also used in developing therapeutics for pulmonary and gastrointestinal diseases, ocular and dermal injuries.

Synedgen is a biotechnology firm that deploys glycochemistry technology to develop drugs that enhance and mimic the innate immune system. – NSMedical