Phase 2 results presented at American Association for Dental Research
Novalar Pharmaceuticals, Inc. has initiated two pivotal Phase 3 studies for NV-101, a vasodilator, being evaluated as a local dental anesthesia reversal agent.
"Following receipt of FDA's written agreement in October 2005 of the design and planned analysis of our pivotal studies through the Agency's Special Protocol Assessment (SPA) process, we have begun the Phase 3 studies in 24 study sites across the United States," said Donna Janson, President and Chief Executive Officer. "These sites include leading dental schools, clinical research organizations and private clinics."
Building on the results from an earlier Phase 2 study, which was presented at the recent American Association for Dental Research annual meeting, these two multi-center, randomized, blinded, controlled Phase 3 studies will assess the safety and efficacy of
NV-101 in reversing soft tissue anesthesia with four leading anesthetics commonly used in dental procedures. In addition, one Phase 2 pediatric study is also underway in children ages 4-11 years. These three clinical studies are expected to be completed
by the end of 2006.
"While local dental anesthesia is the most widely used anesthetic procedure, it frequently results in longer-than-necessary soft tissue numbness due to vasoconstriction induced by local anesthetic solutions," explains Dr. Bruce Rutherford, Novalar's Vice President, Clinical Development. "This persistent numbness creates difficulty in eating, drinking and speaking, and may result in soft tissue damage due to lip, cheek, and tongue biting. Previous clinical studies confirmed that NV-101 may reduce the time to normal lip sensation by approximately 50 percent when compared to placebo. Additionally, 43 percent of NV-101 patients vs. 3 percent of placebo patients reported a
return to normal lip sensation within the first hour."