FDA Approves Dental Numbness Reversal Drug

Are you one of the many who dread the after effects of numbing during dental work? Help is on the way; no more drooling or slurred speech! Recently the FDA approved a new drug to reverse the effects of local anesthetics used by dentists. Called OraVerse, it is the first drug of its kind, and has been approved for adults and children over the age of six and weighing more than 33 pounds.

OraVerse, developed by Novalar Pharmaceuticals, will begin selling to dentists later this year. They plan to sell the injections at a cost of $12.50 per dose. OraVerse is a formulation of a drug that is decades old and used to treat severe hypertension, called phentolamine mesylate. OraVerse works by dilating blood vessels, resulting in faster blood flow, allowing for the anesthetic to be carried away faster. This is the opposite of what happens when the dentist administers a local anesthetic. Local anesthetics are usually combined with epinephrine, which actually constricts the blood flow, not allowing the anesthetic to dissipate from the mouth area too quickly.

During two trials, conducted by the pharmaceuticals company, 484 patients were evaluated while being given either OraVerse or a control injection. The patients were blindfolded, preventing them from being able to see the needle and tell if the needle penetrated their skin. Then observers tapped patient's lips every five minutes over a five hour period to check for sensation. Observers also evaluated the symmetry of patient's smiles, watched for drooling and evaluated them when reading sentences. The tests did not involve patients who had root canals or tooth extractions, because of the tendency to have lingering pain and the possible need for pain relief, says Dr. Paul A. Moore, chairman of anesthesiology, at the University of Pittsburgh School of Dental Medicine.

Tests resulted in 41 percent of patients having normal lip sensation one hour after receiving OraVerse, in comparison to only 7 percent feeling normal lip sensation with the control injection. Twelve percent of the group receiving the control injection reported normal sensation in their bottom lips, after an hour, compared to 59 percent of those that received OraVerse. Novalar reported no serious side effects found during research, but the most common side effect was pain at the injection site.

During Novalar's surveys to ascertain the demand for this type of drug, many dentists and consumers showed great interest in the product. It may even be a drug dentists use as a source of profit, especially with over 300 million anesthesia injections being administered by dentists annually. Novalar executives anticipate the drug reaching sales of hundreds of millions of dollars annually.

If patients are willing to pay the cost for the injection, by the end of the year, they may benefit from the new drug preventing bitten tongues, the need for a napkin to wipe the drool from their mouths and prevent postponing meals because of difficulty eating. OraVerse has shown to help regain sensation to the soft tissue of the mouth within 75 to 85 minutes, or half of the previous time it took to regain sensation. Novalar plans to launch the new drug during American Dental Association's Annual Session October 16th through 20th, 2008. Following the annual session, sales teams for Novalar will focus sales toward general and pediatric dentists.