The FDA has approved St. Renatus’s Kovanaze tetracaine HCl and oxymetazoline HCl nasal spray, the company announced. The product is approved for regional anesthesia for adults and children weighing 40 kg or more who are having work done on the upper incisors, canines, or premolars.
The company announced positive results from a Phase 3 study of the nasal spray in early 2014 and in March of that year said that it had raised $5 million for completion of the NDA, which it expected to submit by the end of 2014.
St. Renatus CEO Steve Merrick commented, “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.”
Read the St. Renatus press release.
