St. Renatus begins Adult Phase 3 clinical trials

FORT COLLINS, Colorado--The Adult Phase 3 clinical trials, testing St. Renatus’ needle‐free dental anesthetic, have officially begun.

The first subjects were dosed Aug. 9, 2012, at Jean Brown Research Facility in Salt Lake City, Utah. The trials will further test the wide-scale safety and efficacy of the nasal mist on a total of 380 adult subjects. They will also undergo dental procedures at various sites in the coming months.

The amended Adult Phase 3 protocol was submitted to the U.S. Food and Drug Administration 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.

“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 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 clinical and nonclinical trials are complete, St. Renatus hopes to susubmit a New Drug Application to the FDA with a goal of having the approval sometime during 2013.

For more information, visit www.st‐renatus.com or call (970) 282-0156.

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