Novalar's NV-101 meets Ph II efficacy endpoints

The USA's Novalar Pharmaceuticals says that NV-101, its local dental anesthetic reversal agent, met its safety and efficacy endpoints in a Phase II pediatric study. According to the firm, time-to-normal-sensation was reduced 55.6%, a clinically and statistically significant (p<0.0001) acceleration of the return-to-normal-sensation. As was seen in Phase III studies of the drug in adolescents and adults, NV-101 continued to be well-tolerated with no serious adverse events reported in the pediatric population studied.

The randomized, blinded, controlled study was designed to evaluate the safety and efficacy of NV-101 in the reversal of soft tissue anesthesia in subjects aged between four and 11 years undergoing dental or periodontal maintenance procedures in the lower or upper jaw after receiving local anesthesia. Novalar plans to submit a US New Drug Application for NV-101 in 2007.