Synedgen receives FDA clearance for Synvaza mouth rinse


Synvaza is an oral wound rinse said to prevent irritation and help manage pain.

Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an over-the-counter (OTC)  mouth rinse.

Synvaza Mouth Sore and Wound Rinse has been approved for marketing OTC, joining the company’s oral health products Moisyn and Moisyn Mist for dry mouth, and Synedent® and Synedent® FLX oral rinses.

“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,” said Shenda Baker, Ph.D., president and CEO of Synedgen. “Synedgen is uniquely positioned to improve oral health across multiple patient segments.”

Synvaza is an oral wound rinse formulated with ChitoTech, mucoadhesive, hygroscopic biopolymers that form a protective barrier around oral wounds, which is said to prevent irritation and help manage pain. This formulation is designed to provide a moist wound environment for optimal wound healing.

In a clinical study, Synvaza was shown to decrease pain associated with ulcerative oral lesions. Patients reported decreases in oral soreness related to drinking, swallowing, eating, talking, and sleeping. Pain relief was reported by patients including those with aphthous stomatitis, oral lichen planus, and chronic graft versus host disease. Studied lesions were associated with medications, cancer treatment, acid reflux, and other underlying conditions.

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