FORT COLLINS, Colo., Feb. 21, 2014 /PRNewswire/ -- 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.
ABOUT ST. RENATUS
St. Renatus, LLC was founded to develop a revolutionary innovation - the world's first dental anesthetic administered through the nasal cavity designed for use in procedures involving most of the upper teeth, with a goal of gaining FDA approval to commercialize and distribute. St. Renatus' name comes from the patron saint of anesthesia and has Latin roots meaning new beginning.
St. Renatus believes the benefits of its product will provide a better experience for doctors and qualifying patients. These benefits could include an accurate and sophisticated method to anesthetize the upper teeth topically, without the use of a dental needle injection.
For more information, please visit www.st-renatus.com or call 970.282.0156.
This document contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. The statements include expectations regarding the clinical studies and the potential for the drug product. They are based on the Renatus' current intentions, beliefs and expectations regarding future events. St. Renatus cannot guarantee that the forward-looking statements will be accurate, though they do represent St. Renatus' judgment as of the date of this release. St. Renatus and we disclaim, however, any intent or obligation to update these forward-looking statements.
St. Renatus, LLC., 1000 Centre Avenue, Fort Collins, CO 80526
Toll Free: 1.888.686.2314 P: 970.282.0156 F: 970.221.4365
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SOURCE St. Renatus, LLC