OraVerse receives FDA approval

The Food and Drug Administration has granted market approval for the use of phentolamine mesylate in the reversal of soft-tissue anesthesia and the associated functional deficits resulting from local dental anesthetic.

The drug will be sold under the brand name OraVerse and the drug’s manufacturer, Novalar Pharmaceuticals Inc., said it plans to launch the product at the ADA’s annual session in San Antonio in October.

According to a Novalar press release, the approval was based on two clinical studies comprising 484 patients.

“OraVerse will provide dentists with a new solution to enhance the overall experience for their patients,” said Donna Janson, Novalar president and chief executive officer. “Market research conducted by Novalar indicated that the primary benefits seen by dental professionals include reduced risk of injury during the period while patients are anesthetized and increased patient satisfaction.”

Both studies were randomized, double-blinded and placebo-controlled Phase 3 studies. OraVerse or the placebo solution was injected at the site of local anesthesia administration after the completion of the operative dental procedure. In the cases where patients were given OraVerse instead of the placebo, the drug was found to reduce the median time to recovery of normal sensation in the lower lip by 85 minutes and 83 minutes in the upper lip. Also, the company reported that within one hour after receiving OraVerse, 41 percent of patients reported normal lower lip sensation as compared to 7 percent in the control group, and 59 percent of patients reported normal upper lip sensation compared to 12 percent.

Phentolamine mesylate is an alpha-adrenergic blocking agent. Though tachycardia and cardiac arrhythmia may occur with the injection of drugs in this class, such events are reported to be uncommon after submucosal administration of OraVerse. No serious adverse events were reported in the studies and the most common adverse reaction that was greater than control was transient injection site pain. OraVerse is not recommended for use in children 6 or younger or weighing less than 33 pounds.

For details, visit www.novalarpharm.com .聽