Breakthrough Therapy Designation for Silver Diamine Fluoride granted by FDA
Redmond, OR and West Palm Beach, FL – Advantage Silver Dental Arrest and Elevate Oral Care have announced that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Therapy Designation” to Advantage Arrest™ Silver Diamine Fluoride 38% for the arrest of tooth decay in children and adults.
Breakthrough Therapy Designation represents the FDA’s effort to address an unmet, serious, life-threatening medical need where there is no available therapy. It is a process designed to expedite the development and review of drugs that are intended to treat a serious condition as soon as possible and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s).
In use for over 80 years as a caries-arresting drug in Japan and other countries, the Designation was granted based on the FDA review of 10 worldwide randomized clinical trials evaluating silver diamine fluoride for caries arrest in children aged 3-9 or adults aged 60-89, as well as studies conducted by Advantage Silver Dental Arrest, LLC. Collectively these trials involved approximately 1500 subjects who were monitored for 1-3 years.
Currently, Advantage Arrest Silver Diamine Fluoride 38% is cleared by the FDA as a medical device for the treatment of dentinal hypersensitivity. It is well known that since it received FDA clearance in 2014 and became commercially available in April 2015, the material has been used extensively by oral health professionals in the U.S. off-label for the arrest of dental caries.
The American Dental Association added a new Code on Dental Procedures and Nomenclature (CDT Code D1354 – Interim Caries Arresting Medicament Application) to achieve uniformity, consistency and specificity in accurately documenting treatment for the efficient processing of dental claims. Multiple insurers and State Medicaid programs are currently reimbursing for the cost of the therapy for caries arrest.
“The Breakthrough Therapy Designation represents a major milestone in our over eight year effort, spearheaded by Dr. Peter Milgrom of Advantage and the University of Washington, to improve the treatment of severe early childhood dental caries, a serious and rampant disease,” said Dr. Mike Shirtcliff, president of Advantage Silver Dental Arrest.
Kevin Thomas, president of Elevate Oral Care, the commercialization organization for Advantage Arrest Silver Diamine Fluoride 38% stated, “We are proud to be a part of this exciting advancement that fills such a huge unmet need.”