A Phase 2 Study of Novalar Pharmaceuticals, Inc.’s local dental anesthetic reversal agent – NV-101- recently met its safety and efficacy endpoints in pediatric patients where the time to normal sensation was reduced by 55.6 %, a clinically and statistically significant (p<0.0001) acceleration of the return to normal sensation.
According to Donna Janson, Novalar's President and Chief Executive Officer:
"These pediatric results complement our recently announced Phase 3 efficacy data in adolescents and adults, supporting the broad and safe use of NV-101 for patients as young as 4 years of age.
These positive results will be an important addition to our New Drug Application (NDA) for NV-101 in 2007, and, if approved, will contribute towards the adoption of this novel agent for dental patients."
The said study was designed to evaluate the safety and efficacy of NV-101 in the reversal of soft tissue anesthesia (STA) in pediatric subjects (ages 4-11) undergoing dental or periodontal maintenance procedures in the mandible (lower jaw) or maxilla (upper jaw) after receiving local anesthesia.
Find more details from the press release.
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