Kovanaze is a nasal spray, similar to the one pictured, approved for use by the FDA as an anesthetic for restorative dental work. Photo by Becton, Dickinson and Company
PHILADELPHIA, Aug. 26 (UPI) -- For people who are pain- or needle-phobic, dental work is often avoided because the primary method for numbing the mouth involves a shot, but a new inhalable anesthetic may offer new hope to those avoiding the dentist.
The U.S. Food and Drug Administration has approved Kovanaze, a nasal spray anesthetic for use in restorative dental work after it was shown to be safe and effective in clinical trials.
The drug, developed by the company St. Renatus, was inspired by a nasal spray containing the anesthetic tetracaine when the company's co-founder, Mark Kollar, had surgery for a deviated nasal septum.
Kollar, a dentist, noticed his teeth went numb, in addition to his face, after receiving the inhalable anesthetic and started working on a version that might be useful for his own patients.
Kovanaze, which is a combination of tetracaine and the nasal decongestant oxymetazoline, was approved by the FDA for use with patients over 88 pounds, though the company plans to investigate its use with children, as well as for other procedures.
"It would certainly make for a more stress-free dental office visit for children as well as adults if we could replace some of these anesthetic injections with a simple spray," Dr. Elliot Hersh, a professor at the University of Pennsylvania's dental school and collaborator on the recent phase 3 clinical trial for Kovanaze, said in a press release. "It may also keep some children out of the operating room, which would be a major cost savings to the child's family and reduce potential morbidity associated with general anesthetic procedures."
For the phase 3 trial, the results of which are published in the Journal of the American Dental Association, researchers recruited 150 participants to receive either Kovanaze or placebo before restorative dental work. Each participant received two 0.2-millimeter sprays four minutes apart, and a third if they were not numb enough. If the sprays were not enough, patients could also receive an rescue shot of anesthetic.
Participants were monitored for adverse reactions to the drug, given smell tests and had vital signs taken during the 2-hour study period and a day later in a follow-up visit.
More than 88 percent of patients receiving Kovanaze found it effective, a rate researchers say is comparable to commonly used injectable numbing agents, with the most common side effects being a runny nose and nasal congestion.
The company is likely to conduct trials and seek approval for the drug to be used with root canals and oral tissue biopsies, among other more intensive dental procedures, as well as whether it is safe with children, Hersh said.
"There is really nothing else like this out there," Hersh said. "This is obviously a great thing for needle-phobic individuals, and it can reduce inadvertent needle-stick injuries in the clinic as well."