St. Renatus completes Phase 3 studies on intranasal dental anesthetic

St. Renatus has announced the completion of adult and pediatric Phase 3 clinical studies of its nasal mist dental anesthesia and says that it is now working on data analysis with the goal of submitting an NDA for the product in 2014. The nasal anesthetic numbs the upper teeth without affecting the patient’s lips or face.

St. Renatus CEO Steve Merrick commented, “We are very pleased with how the nasal mist has performed in our Phase 3 studies. Completing Phase 3 is a critical milestone for a new drug; it is rare for investigative new drugs to get this far in the process. The next big milestone is locking the study data and completing the statistical analysis for these Phase 3 studies. We are looking forward to completing the analysis and are hopeful it will depict a positive, safety and efficacy profile of our drug, so that we can continue toward FDA submission, review and final approval.”

In early 2012, the company announced that it raised $3.5 million for the Phase 3 trials and said that it planned to complete the studies and file an NDA by the middle of that year.

Read the St. Renatus press release.