Synedgen has received 510(k) clearance from the Food and Drug Administration to market its Synvaza Mouth Sore and Wound Rinse over-the-counter product.
“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,” said Shenda Baker, PhD, president and CEO of Synedgen.
“Synvaza also provides an innovative solution for patients with many types of oral wounds, including traumatic ulcers and surgical injuries,” Baker said.
Synvaza is an oral wound rinse formulated with ChitoTek mucoadhesive, hygroscopic biopolymers that form a protective barrier around oral wounds to prevent irritation and help manage pain. It provides a moist wound environment, Synedgen said, which is optimal for wound healing.
In a clinical study, Synedgen said, Synvaza decreased pain associated with ulcerative oral lesions. Patients reported decreases in oral soreness related to drinking, swallowing, eating, talking, and sleeping.
Also, 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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