PHILADELPHIA, Sept. 16, 2016 /PRNewswire-USNewswire/ -- A fear of pain causes many people with dental phobias to avoid or delay needed treatment. In some cases, the injection of a numbing agent can be the most painful part of the visit. But with a new FDA-approved anesthetic, administered with a brief nasal spray, that injection may not be necessary.
The spray, a drug called Kovanaze, was deemed safe and effective in a recent Phase 3 clinical trial led by Penn Dental Medicine researchers; the results were published in the Journal of the American Dental Association.
"There is really nothing else like this," said Dr. Elliot Hersh, the study's lead author and Professor of Pharmacology at Penn 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 double-blind, randomized trial found that the compound, a combination of the local anesthetic tetracaine and the nasal decongestant oxymetazoline, was effective at preventing pain during a single restorative procedure in an upper bicuspid, canine, or incisor in 88 percent of patients – a rate comparable to the success of commonly used injectable numbing agents. The most common side effects were runny nose and nasal congestion; no serious side effects were reported.
Kovanaze was developed by St. Renatus and received FDA approval June 29.
To lead the Phase 3 trial, St. Renatus turned to Hersh, who had previously evaluated the safety and efficacy of a number of analgesic drugs, including an early study on Kovanaze.
The trial recruited 150 adults set to undergo a single dental filling in an upper bicuspid, canine, or incisor. One hundred patients were assigned Kovanaze and 50 were assigned a placebo spray.
Patients received one spray, waited four minutes, received a second spray, waited 10 minutes and then a test drilling was performed. If they experienced pain, they received a third spray. Patients who still experienced pain at that point received a rescue injection of local anesthetic for the procedure.
To follow up on the study, Hersh said the company will likely pursue investigations to see if more invasive dental procedures can be performed using this anesthetic. It's likely that further studies will also evaluate whether it can be safely administered to children. Current FDA approval is for a single maxillary restorative procedure in individuals weighing at least 88 pounds.
The research was supported by a grant from St. Renatus.
Contact: Beth Adams, 1-215-573-8224, [email protected]
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The spray, a drug called Kovanaze, was deemed safe and effective in a recent Phase 3 clinical trial led by Penn Dental Medicine researchers; the results were published in the Journal of the American Dental Association.
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"There is really nothing else like this," said Dr. Elliot Hersh, the study's lead author and Professor of Pharmacology at Penn 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 double-blind, randomized trial found that the compound, a combination of the local anesthetic tetracaine and the nasal decongestant oxymetazoline, was effective at preventing pain during a single restorative procedure in an upper bicuspid, canine, or incisor in 88 percent of patients – a rate comparable to the success of commonly used injectable numbing agents. The most common side effects were runny nose and nasal congestion; no serious side effects were reported.
Kovanaze was developed by St. Renatus and received FDA approval June 29.
To lead the Phase 3 trial, St. Renatus turned to Hersh, who had previously evaluated the safety and efficacy of a number of analgesic drugs, including an early study on Kovanaze.
The trial recruited 150 adults set to undergo a single dental filling in an upper bicuspid, canine, or incisor. One hundred patients were assigned Kovanaze and 50 were assigned a placebo spray.
Patients received one spray, waited four minutes, received a second spray, waited 10 minutes and then a test drilling was performed. If they experienced pain, they received a third spray. Patients who still experienced pain at that point received a rescue injection of local anesthetic for the procedure.
To follow up on the study, Hersh said the company will likely pursue investigations to see if more invasive dental procedures can be performed using this anesthetic. It's likely that further studies will also evaluate whether it can be safely administered to children. Current FDA approval is for a single maxillary restorative procedure in individuals weighing at least 88 pounds.
The research was supported by a grant from St. Renatus.
Contact: Beth Adams, 1-215-573-8224, [email protected]
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/penn-dental-medicine-study-finds-nasal-spray-safe-and-effective-anesthesia-for-dental-work-300329127.html
SOURCE Penn Dental Medicine
