St. Renatus, LLC., has completed all planned FDA Clinical Studies
of a Nasal Anesthetic for Dentistry.
Analysis by the Company of Phase 3 efficacy studies of Nasal Mist Technology for Dental Anesthe
Posted: February 26, 2014
FORT COLLINS, Colo. – February 21, 2014 – St. Renatus, LLC, announced today that the company has completed Phase 3 clinical studies and is preparing its analysis for submission to the U.S. Food
and Drug Administration (FDA). The studies tested the safety and efficacy of St. Renatus’ nasal mist technology in adult and pediatric subjects.
St. Renatus conducted its pediatric Phase 3 studies at multiple sites around the country where pediatric patients ranging in age from 3 to 17 years were administered the nasal mist instead of needle based dental anesthesia.
“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,” said Steve Merrick, Chief Executive Officer for St. Renatus, LLC. “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.”
St. Renatus’ nasal mist technology was required to complete three phases of clinical human studies by the FDA. St. Renatus completed Phase 1 clinical human studies in 2007, Phase 2 studies were conducted from 2008 through 2011 and the company completed an End of Phase 2 Meeting with the FDA in March 2011. Phase 3 studies began early in 2013 and were completed in the fourth quarter of 2013, and are the last phase of clinical studies required by the FDA prior to submission for approval.
Preliminary data is being analyzed by St. Renatus and its team of qualified consultants. The statistical
results will be the foundation of the New Drug Application (NDA), which the company plans to submit
to the FDA for review in 2014.
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