A promising new pain management treatment has been found to be safe and effective, and researchers believe that it can be successfully used in the dental office. The nasal spray Kovanaze was just put through a Phase 3 clinical trial, meaning it was given to a large group of people to confirm its effectiveness and monitor side effects. With promising results, the drug could help millions of individuals who suffer from dental phobia, especially those with a fear of needles.
“There is really nothing else like this out there,” said Elliot V. Hersh, the study’s lead author and professor at the University of Pennsylvania School of Dental Medicine. “This is obviously a great thing for needle-phobic individuals, and it can reduce inadvertent needle-stick injuries in the clinic as well.”
The compound of the local anesthetic tetracaine and the nasal decongestant oxymetazoline was used in a randomized, double-blind trial. Researchers found Kovanaze to be effective at preventing pain during a single restorative procedure in an upper bicuspid, canine, or incisor in 88% of patients, according to a recent article from Futurity.org. This rate is comparable to the success of common injectable numbing agents. The most common side effects include runny nose and nasal congestion with no serious side effects reported.
The drug was developed by St. Renatus, LLC, a privately held company based in Fort Collins, Colorado. The idea for Kovanaze, or K305, came after Mark Kollar, St. Renatus co-founder had an accident which required 21 stitches and a septum repair. Kollar’s ENT gave him a nasal spray containing tetracaine to remove a nasal stent, which is when he noticed that his teeth were numb. Kollar, a practicing dentist, confirmed the side effect at his office, using a dental electronic pulp stimulator at his office. The possibilities of using the drug in the dental office were discovered.
The trial of K305 began with 150 adults who were set to undergo a single dental filling in an upper bicuspid, canine, or incisor. 100 of the patients were given the drug and 50 were given a placebo. Patients received a series of 2 to 3 sprays over the course of about 15 minutes. Patients who still experienced pain at this point were given a rescue injection of local anesthetic to complete the procedure. Of those given Kovanaze, 88% were able to have the procedure completed without the injection, compared to 28% for the placebo spray.
Side effects observed during the trial included a slight rise of blood pressure in some patients. Nasal congestion, nasal discomfort, throat pain and irritation, headache, and eye watering were also reported, but no serious adverse effects were documented.
St. Renatus plans to follow up the study with additional research to see if more intensive procedures, like root canals or oral tissue biopsies, can be performed using the anesthetic. Further studies will also likely be conducted to determine if the drug can be safely administered to children. The drug has received FDA approval for use on individuals weighing at least 40 kilograms, or about 88 pounds.
“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,” Hersh stated. “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.”