NOVALAR ANNOUNCES RESULTS OF DENTAL ANESTHESIA REVERSAL STUDY

Novalar Pharmaceuticals has announced that NV-101, a local dental anesthetic reversal agent, was well-tolerated and met its primary endpoints in two Phase III studies. In both trials, patients treated with NV-101 reported the return of sensation in less than half the amount of time it normally took after receiving local dental anesthesia.

The two multicenter, randomized, blinded, controlled studies, conducted under a Special Protocol Assessment, took place 18 centers across the United States, including dental schools, clinical research organizations and private clinics. There were 484 dental patients enrolled across the two studies, including adolescents and adults. In the first study, 244 patients received anesthesia in the mandible (lower jaw) and in the second study, 240 patients were administered anesthesia in the maxilla (upper jaw). Following anesthesia and completion of the dental procedure, patients were administered either NV-101 or placebo.

NV-101-treated patients experienced return of sensation in less than half the amount of time after receiving local dental anesthesia with a statistically significant 54.8 percent decrease in time for those with anesthesia administered in the mandible compared with the control group and a statistically significant 62.3 percent decrease in time for those with anesthesia administered in the maxilla compared with the control group.

Market research studies have indicated strong levels of interest for NV-101. Patients and dentists identified opinions toward local dental anesthesia and expressed interest in decreasing time to return of normal sensation.