For those who don’t like to drool, slur their speech or unknowingly bite their tongue after a visit to the dentist, help might be at hand.
A small drug company said it won approval Friday from the Food and Drug Administration to market the first drug meant to undo the effects of local dental anesthesia.
In clinical trials, the drug cut the median time it took for full sensation to return to the lips by about 75 minutes to 85 minutes, or by about half.
The drug, called OraVerse, was developed by Novalar Pharmaceuticals, a privately held company in San Diego. The company said it would begin selling the drug to dentists late this year for $12.50 an injection.
After a dentist finished a filling or some other procedure, he or she would inject OraVerse into the same spot where the anesthetic had been injected.
Is a drug really needed for what seems like a trivial use? Novalar and some dentists who advise the company said it might be useful for children, who can injure themselves by biting their lips or tongues without knowing it.
“Kids tend to chew on their tongue when it’s numb,” said Dr. Athena Papas, a professor at the Tufts University School of Dental Medicine. The drug, however, is not approved for children younger than 6 or weighing less than 33 pounds.
Papas, an adviser to Novalar and investigator in its clinical trials, said she thought the drug would appeal especially to those receiving cosmetic dentistry “who like to look good when they leave the dentist’s office.”
Novalar said its surveys showed great interest in the product among consumers and dentists, some of whom said they would mark up the price of the drug as a source of profit.
About 300 million anesthesia injections are given by dentists each year.
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OraVerse is a formulation of a decades-old drug, phentolamine mesylate, which is used to treat severe episodes of hypertension.