A nasal mist local anesthetic aimed at achieving anesthesia in the maxillary arch is moving forward with its efforts to gain U.S. Food and Drug Administration (FDA) approval.
The nasal mist, developed by St. Renatus, recently had a favorable end of phase II clinical trial review with the FDA, the company announced. The phase II results submitted to the FDA indicated that the mist is comparable to that of a standard needle-injected dental anesthetic.
"We are very pleased with how the nasal mist has performed in trials thus far, and with the outcome of our meetings with the FDA," said Steve Merrick, CEO of St. Renatus, in a press release. "We believe it represents a significant step forward for both St. Renatus and the field of dentistry."
According to the company, initial consumer research for the nasal mist product found that if patients are given the choice between a nasal mist anesthetic and a needle-injected anesthetic, 90% of all patients are very or somewhat likely to choose the new product, and 23% are very likely to switch to a dentist offering the nasal spray option. In addition, 96% of dentists surveyed expect to offer the new nasal mist anesthetic to their patients.
St. Renatus expects phase III clinical studies to be completed in the second half of 2011 and plans to file a New Drug Application with the FDA in the latter part of 2011.
