Nasal Spray Utilizing Needle-Free Technology
- Indication: KOVANAZE is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.
- Patients may not experience the same sensations of numbness or tingling of the lips and cheeks associated with injectable anesthetics.
- Kovanaze provides regional anesthesia with 96% efficacy in teeth #5-12, 64% in #4 and #13*, therefore Kovanaze offers a needle-free alternative to the majority of anterior maxillary injections.
*In a Phase 3, randomized, double-blind study comparing the efficacy and safety of KOVANAZE to placebo for providing dental anesthesia sufficient to complete a dental procedure on a single maxillary tooth (#4-13) in adults, 150 patients received either KOVANAZE (n=100) or placebo (n=50) as a dose of two or three 0.2 mL intranasal sprays. Eighty-eight percent of KOVANAZE patients were able to complete the dental procedure without the need for rescue medication compared to 28% of patients who received placebo. KOVANAZE had a lower success rate (64%) for dental procedures on the 2nd pre-molar (teeth #4 and #13) compared with 96% for more anterior teeth (#5 through #12).