Novalar Pharmaceuticals has said that NV-101, a local dental anesthetic reversal agent, met its safety and efficacy endpoints in a phase II study for pediatric patients.
The study was designed to evaluate the safety and efficacy of NV-101 in the reversal of soft-tissue anesthesia in pediatric subjects undergoing dental or periodontal maintenance procedures after receiving local anesthesia.
In this study the time to normal sensation was reduced by 55.6%, a clinically and statistically significant acceleration of the return to normal sensation. As in the phase III studies, NV-101 continued to be well tolerated with no serious adverse events reported in the pediatric population studied.
No differences were apparent in the frequencies or types of adverse effects reported by the two randomized treatment groups.
"These pediatric results complement our recently announced phase III efficacy data in adolescents and adults, supporting the broad and safe use of NV-101 for patients as young as four years of age," said Donna Janson, Novalar's president and CEO.
"The rate of recovery from local anesthesia for children is important because they may have an increased risk of chewing their lips and tongue while numb," explained Dr. Bruce Rutherford, Novalar's vice president, Clinical Development.
"This study demonstrated significant and safe acceleration of return to normal sensation in children which may therefore reduce the chance of injury."