Having a cavity filled could be a lot less unpleasant if St. Renatus LLC succeeds in getting FDA approval of its needle-free dental anesthetic.
The Fort Collins, Colo., company recently completed phase 3 clinical trials of an anesthetic administered through the nasal cavity. Now it’s getting its data analysis ready for submission to the FDA later this year.
To help with all of that, it’s also just secured a $5 million investment from Blue Ocean STR, which was an early investor several years ago, the company announced Tuesday.
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St. Renatus is proposing that its spray, Kovacaine Mist, could be used instead of an injected anesthetic to numb adults and children before fillings, crown preparations or other procedures on their upper teeth. Eliminating pain, needle fear and the “fat lip” numbness associated with injections could result in a better patient experience, the company says on its website.
More than 90 percent of U.S. adults have a cavity by the age of 64.
Instead of a needle prick, patients would experience a different sensation. The spray targets the maxillary nerve, which controls sensation in the upper mouth, sinuses and nasal cavity. It contains a combination of the local anesthetic tetracaine and oxymetazoline hydrochloride, a topical decongestant used in nasal sprays.
In a phase 2 trial published last year, 25 of 30 patients given the spray and a placebo injection did not require further anesthetic during their procedure.
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Recently completed phase 3 trials evaluated the spray in 380 adult subjects, and an additional phase 3 trial tested it on 90 pediatric patients. St. Renatus plans to have its New Drug Application prepared by this summer, according to its website, and begin transitioning from a research company to a commercialization one.
The company’s unusual name was inspired by Rene Goupil, the patron saint of anesthesiologists.
[Image credit: Flickr user Irina Patrascu]