St. Renatus' nasal mist has undergone Phase 1 and Phase 2 clinical trials of the U.S. Food and Drug Administration (FDA) process and is currently in Phase 3 trials. The trials have been conducted at a number of qualified institutions and research facilities throughout the United States. Initial FDA trial results indicate that the nasal mist appears to be safe and effective.
The FDA Phase 2 trials' initial results indicated 90-percent efficacy that is similar to needle injection results. A Pharmacokinetics (PK) trial was completed in the fall of 2010. The first pediatric trial, testing the nasal mist on children under the age of 18, was successfully completed in the fall of 2012 in Fort Collins, Colorado.
The Adult Phase 3 clinical trials officially began on August 9, 2012. St. Renatus anticipates these trials will finish by the summer of 2013. It then plans to submit the new drug application (NDA) to the FDA after the final analysis of Phase 3 trials is conducted and the pre-NDA meeting has occurred. The nasal mist drug approval is anticipated for 2014.