After a favorable end-of-Phase 2 meeting with the FDA, St. Renatus has announced that it plans to proceed to Phase 3 studies of its dental anesthetic, which is delivered as a nasal mist via a syringe. The nasally-administered anesthetic numbs the patient’s teeth without numbing the face and lips.
According to St. Renatus, the Phase 2 results showed that the nasal mist produced comparable results to conventional dental anesthesia injected with a needle.
CEO Steve Merrick said, “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. We believe it represents a significant step forward for both St. Renatus and the field of Dentistry.”
The company plans to complete Phase 3 studies and file an NDA by the end of 2011.
Read the company’s press release.
