The amended Adult Phase 3 protocol was submitted to the U.S. Food and Drug Administration (FDA) in early June 2012. It was also submitted to two of the sites conducting the clinical trials, Jean Brown and University of Maryland Dental School, and received approval from their Institutional Review Boards (IRBs).
“In the next few months we will generate significant data from the general population through adult and pediatric trials, which should show continued safety and efficacy of our investigative drug,” said St. Renatus’ CEO Steve Merrick.
St. Renatus had a favorable ‘End of Phase 2’ meeting with the FDA in early 2011. At this time, details for both Phase 3 Adult and Pediatrics trials were discussed. Since that meeting, St. Renatus has been working diligently to prepare for the final trials, including conducting a pilot study, protocol reviews and consulting from experienced individuals in the dental and medical anesthetic field.
St. Renatus expects to complete the adult Phase 3 clinical trials by the end of 2012. After all clinical and nonclinical trials are complete, St. Renatus hopes to submit a New Drug Application (NDA) to the FDA with a goal of having the approval sometime during 2013.
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 risk, fear, and pain of an injection. Patients would not experience the uncomfortable cheek or "fat lip" numbness associated with the needle.
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 trials 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.
