SAN DIEGO, May 12 Novalar Pharmaceuticals, Inc., a dentalspecialty pharmaceutical company, announced today that the United States Foodand Drug Administration (FDA) has granted marketing approval for OraVerse(TM)(phentolamine mesylate). OraVerse is the first pharmaceutical agent indicatedfor the reversal of soft-tissue anesthesia and the associated functionaldeficits resulting from a local dental anesthetic. Novalar is establishing aspecialty direct sales force to launch OraVerse in late 2008.
"The approval of OraVerse is the result of the outstanding efforts of ourdevelopment team, our strong collaboration with the FDA and our focus andcommitment to realizing the vision of our founder, Dr. Eckard Weber. Thisfirst-in-class therapeutic will provide dental professionals with a novelsolution to enhance the overall experience for their patients," stated DonnaJanson, President and Chief Executive Officer of Novalar.
Novalar plans to launch OraVerse at this year's American DentalAssociation (ADA) Annual Session being held in San Antonio, Texas from October16-20, 2008. Novalar's sales force will focus on general and pediatricdentists for use in patients over six years of age.
Over 300 million cartridges of local dental anesthetic are sold each yearin the U.S. alone. Although widely used, it frequently results in unnecessaryand lingering soft tissue anesthesia and associated functional deficits.Novalar's market research with both patients and dentists has indicated stronginterest in a product that will reduce the time to normal sensation andfunction following local dental anesthesia.
OraVerse's approval for use in adults and children is based on data fromseveral clinical studies, including two Phase 3 studies in adults andadolescents age 12 and older and a Phase 2 pediatric study. The two Phase 3studies were conducted in 18 centers across the United States, includingleading dental schools, clinical research organizations and private clinics.There were 484 dental patients enrolled across the two studies.
In the randomized, double-blinded, controlled Phase 3 studies, followingthe administration of local anesthetics and completion of the dental procedure,patients were administered either OraVerse or control. OraVerse reduced themedian time to recovery of normal sensation in the lower lip (as measured bystandardized lip tapping procedures) by 85 minutes compared to control.OraVerse reduced the median time to recovery of normal sensation in the upperlip by 83 minutes. Within one hour after administration of OraVerse, 41% ofpatients reported normal lower lip sensation as compared to 7% in the controlgroup, and 59% of patients in the OraVerse group reported normal upper lipsensation as compared to 12% in the control group. In both Phase 3 studies,the primary endpoint showed that OraVerse was statistically different comparedto control (p<0.0001).
The multi-center, randomized, double-blinded, controlled Phase 2 pediatricstudy evaluated the safety and efficacy of OraVerse in the reversal of softtissue anesthesia in patients undergoing dental procedures after receivinglocal anesthetic. This study enrolled 152 patients: 96 patients in theOraVerse group and 56 patients in the control group. Of the 152 patientsenrolled, 115 were trainable in the assessment method: 72 patients in theOraVerse group and 43 patients in the control group. The study assessedOraVerse's efficacy through the measurement of time to normal lip sensationfor those trainable in the assessment. The median time to normal sensation inpatients age 6-11 was reduced by 75 minutes for the OraVerse treated group, a56% acceleration of the time to normal sensation.
In all OraVerse clinical trials, there were no serious adverse eventsreported and the most common adverse reaction that was greater than controlwas transient injection site pain. Although tachycardia