St. Renatus, LLC Announces the Product Launch of Kovanaze™ Nasal Spray, the First FDA-Approved, Needle-Free Dental Anesthesia, at the 2016 American Dental Association (ADA) Meeting
DENVER-- St. Renatus, LLC announced today that Kovanaze™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray, the first FDA-approved, needle-free, regional dental anesthesia for the maxillary arch, is available for pre-order. The Kovanaze product launch coincides with the American Dental Association's annual meeting in Denver, October 20-24.
Approved by the U.S. Food and Drug Administration (FDA) on June 29, 2016, Kovanaze is indicated for regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children weighing more than 40 kg.
In Phase 3 clinical trials, use of Kovanaze in the anterior maxillary region during restorative procedures resulted in 96 percent efficacy in teeth 5-12 and 63 percent efficacy in teeth 4 and 13. Additionally, patients may not experience the same sensation of numbness or tingling of the lips and cheeks associated with injectable dental anesthetics.
"It is a significant moment in dentistry as a new delivery method for pain management is now available," said Steve Merrick, St. Renatus, Chief Executive Officer. "For decades, needles have been the mainstay for delivering dental anesthesia; now dentists have the option to offer patients a regional anesthesia via a nasal spray for restorative procedures in the smile zone."