Silver Diamine Fluoride Receives New FDA Designation

The United States Food and Drug Administration (FDA) has granted “Breakthrough Therapy Designation” to silver diamine fluoride (SDF) (38%) for the arrest of dental caries. It is the first such drug to receive designation for the purpose of arresting caries and is the first oral care medicine to be distinguished by the FDA as a breakthrough therapy. The breakthrough therapy designation represents the FDA’s effort to expedite the development and review of drugs that are intended to treat a serious condition; it is granted when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies.

SDF has been used for decades as a caries

arresting drug in other countries, and the FDA’s decision came after its review of 10 randomized controlled trials, in which data were collected from more than 1,500 participants over 1 year to 3 years. The FDA cleared SDF for the treatment of dentinal hypersensitivity in April 2015, at which time it became commercially available—though it was used off-label for the arrest of dental caries. Advantage Silver Dental Arrest LLC (Redmond, Oregon) developed SDF for the US market, while Elevate Oral Health LLC (West Palm Beach, Florida) oversaw its commercialization.

From Dimensions of Dental Hygiene. January 2017;15(1):11.