FDA Approves Intranasally Administered, Needleless Dental Anesthetic.

miércoles, 31 de agosto del 2016


UPI 8/26, Feller) reported in continuing coverage that the US Food and Drug Administration has approved Kovanaze, “a nasal spray anesthetic” for use during a restorative procedure “after it was shown to be safe and effective in clinical trials.” The FDA approved Kovanaze, which is a combination of tetracaine and the nasal decongestant oxymetazoline, “for use with patients over 88 pounds, though the company plans to investigate its use with children, as well as for other procedures.” The article noted that the results of the phase 3 trial are published in The Journal of the American Dental Association.

         In a release carried on EurekAlert (8/25), the University of Pennsylvania stated Kovanaze “was deemed safe and effective in a recent Phase 3 clinical trial led by University of Pennsylvania School of Dental Medicine researchers.” Dr. Elliot V. Hersh, the study’s lead author and a professor in the Department of Oral and Maxillofacial Surgery/Pharmacology at Penn Dental Medicine, said, “This is obviously a great thing for needle-phobic individuals, and it can reduce inadvertent needle-stick injuries in the clinic as well.”

         The ADA (7/15) had reported previously that “Kovanaze™ is indicated for regional pulpal anesthesia when performing a restorative procedure on teeth 4 through 13 and A through J in adults and children who weigh 40 kg (88 lbs) or more.” 


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