Monday February 24, 2014 0 commentsFORT COLLINS - St. Renatus LLC announced it has completed Phase 3 clinical studies and is preparing its analysis for submission to the U.S. Food and Drug Administration.
The studies tested the safety and efficacy of St. Renatus' nasal mist technology in adult and pediatric subjects, the company said.
St. Renatus conducted its pediatric Phase 3 studies at multiple sites across the nation, where patients ranging from 3 to 17 years were administered the nasal mist instead of needle-based anesthesia.
"We are very pleased with how the nasal mist has performed in our Phase 3 studies," said Steve Merrick, St. Renatus CEO. "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.
"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."
The company said it plans to submit a New Drug Application to the FDA this year.