Monday January 14, 2013 0 comments
FORT COLLINS - St. Renatus, a bioscience startup focused on developing a nasal spray anesthetic for needle-free dentistry, told investors its product is in final development, with a New Drug Application to the FDA expected this year.
In a letter to investors, the company said Adult Phase 3 trials should be completed in the first half of 2013. The letter also noted that a pediatric clinical trial was completed with no serious adverse events recorded.
St. Renatus also listed a reduced drug dosage as one of its major accomplishments of 2012, with one or two sprays in the nostril on the side of the mouth where the tooth is being treated as sufficient instead of spraying each nostril three times.
"One of the first rules of anesthesia is to achieve anesthesia with the least amount of drug required," the letter said. "With the work done in 2012, St. Renatus has reached this goal and we have the data to prove it. We are very excited with the preliminary results of this reduced dosing method."
The company also noted that it will develop a protocol for the Pediatric Phase 3 clinical trial in the months ahead at a site yet to be determined.
For more information, visit www.St.Renatus.com.