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exhibitors 22 Greater New York Dental Meeting — Nov. 30, 2016 Ad By St. Renatus Staff n The United States Food and Drug Administration (FDA) approval of Kovanaze™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray is a major milestone in St. Renatus’ 11-year effort to offer practition- ers and patients an alternative to injectable anesthesia in the maxil- lary arch. Clinical trials verified the long- standingsafetyprofilesoftetracaine and oxymetazoline, the active ingredients in Kovanaze, and more importantly, demonstrated 96 per- cent efficacy in teeth Nos. 5-12 and 63 percent in teeth Nos. 4 and 13, in providing regional anesthesia to the teeth of the anterior maxilla via nasal spray. During drug development, St. Renatus was required to complete three phases of clinical human stud- ies with the FDA. St. Renatus com- pleted Phase 1 clinical human trials in 2007, Phase 2 studies in January 2009 and completed the required “End of Phase 2 Meeting” (EOP2) with the FDA in March 2011. The Adult Phase 3 clinical trials officially began on August 9, 2012, and were completed on May 17, 2013. St. Renatus completed the Pediatric Phase 3 trials in August 2013. The company attended the Pre-New Drug Application (NDA) Meeting with the FDA on August 21, 2014. The FDA’s input regarding the company’s clini- cal trials and manufacturing data was very helpful to the St. Renatus team. The NDA was submitted to the FDA on May 29, 2015, and approved June 29, 2016. Indication Kovanaze is indicated for regional anesthesia when performing a restorative procedure on teeth Nos. 4-13 and A-J in adults and children who weigh 40 kg or more. Contraindications include known hypersensitivity to tetracaine, ben- zyl alcohol, other ester local anes- thetics, p-aminobenzoic acid (PABA), oxymetazoline or any other com- ponent of the product. Visit www. kovanaze.com for full prescribing information. How well does Kovanaze work? Kovanaze provides 96 percent effi- cacyinteethNos.5-12and63percent in teeth Nos. 4 and 13, as reported from the Phase 3 adult clinical trials. Therefore, Kovanaze offers a needle- free alternative to the majority of anterior maxillary injections. Addi- tionally,patientsmaynotexperience the same sensations of numbness or tingling of the lips and cheeks associated with injectable dental anesthetics. When is it available? Orders are being taken at booth No. 5040 here during the Greater New York Dental Meeting. Orders will be fulfilled by the dental profes- sional’s preferred dental dealer. For more information, contact your dental dealer, visit www. kovanaze.com or call the Kovanaze Support Line at (800) 770-9400. Kovanaze anesthetic nasal spray is here Here in New York To learn more about Kovanaze and place orders, visit St. Renatus at booth No. 5040. You can also learn more at www.kovanaze.com or call the Kova- naze support line at (800) 770-9400. 5 Kovanaze Nasal Spray is available to be ordered at the St. Renatus booth, No. 5040. (Photo/Provided by St. Renatus)