The FDA has granted marketing approval for the OraVerse™ (phentolamine) injection by Novalar Pharmaceuticals Inc. OraVerse is the first pharmaceutical agent indicated for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic.
“The approval of OraVerse is the result of the outstanding efforts of our development team, our strong collaboration with the FDA, and our focus and commitment to realizing the vision of our founder, Dr Eckard Weber,” said Donna Janson, president and CEO of Novalar. “This first-in-class therapeutic will provide dental professionals a novel solution to enhance the overall experience for their patients.”
OraVerse’s approval for use in adults and children is based on data from several clinical studies, including two Phase 3 studies in adults and adolescents age 12 and older and a Phase 2 pediatric study.
In the controlled Phase 3 studies, following the administration of local anesthetics and completion of the dental procedure, patients were administered either OraVerse or control. OraVerse reduced the median time to recovery of normal sensation in the lower lip (as measured by standardized lip-tapping procedures) by 85 minutes compared to control. OraVerse reduced the median time to recovery of normal sensation in the upper lip by 83 minutes. Within 1 hour after administration of OraVerse, 41% of patients reported normal lower-lip sensation compared to 7% in the control group, and 59% of patients in the OraVerse group reported normal upper-lip sensation compared to 12% in the control group.
The controlled Phase 2 pediatric study evaluated the safety and efficacy of OraVerse in the reversal of soft-tissue anesthesia in patients undergoing dental procedures after receiving local anesthetic. This study included 152 patients—96 patients in the OraVerse group and 56 patients in the control group. Of the 152 patients enrolled, 115 were trainable in the assessment method—72 patients in the OraVerse group and 43 patients in the control group. The study assessed OraVerse’s efficacy through the measurement of time to normal lip sensation for those trainable in the assessment. The median time to normal sensation in patients ages 6 to 11 was reduced by 75 minutes for the OraVerse-treated group, a 56% acceleration of the time to normal sensation.
The researchers reported no serious adverse events. The most common adverse reaction that was greater than control was transient injection-site pain.
The company plans to launch OraVerse at this year’s ADA annual session, which will be held in San Antonio from October 16 to 20.
For more information, visit www.novalarpharm.com.
