St. Renatus LLC, a privately held company based in Fort Collins, Colorado, announced today that it received US Food and Drug Administration (FDA) approval on June 29, 2016, for its first product, Kovanaze, a dental anesthetic (tetracaine HCl and oxymetazoline HCl) nasal spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.
"For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia," said Steve Merrick, CEO of St. Renatus.
Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic but without the needle.
Kovanaze is indicated for regional anesthesia when performing a restorative procedure on Teeth 4–13 and A–J in adults and children who weigh 40 kg or more.
Source: St. Renatus press release, 12 July 2016