An interview with St. Renatus CEO Steve Merrick about the development of Kovanaze, the first FDA-approved no-needle regional, pulpal anesthetic administered via nasal spray
The approval of Kovanaze by the US Food and Drug Administration (FDA) signals a significant inflection point in the development of needle-free anesthesia delivery systems for dentistry. Can you provide a high-level clinical overview of the product’s development?
The US Food and Drug Administration (FDA) approval of Kovanaze is a major milestone in St. Renatus’s 11-year effort to offer practitioners and patients an alternative to injectable anesthesia in the maxillary arch. Our clinical trials verified the longstanding safety profiles of tetracaine and oxymetazoline, the active ingredients in Kovanaze, and more importantly, demonstrated 96% efficacy (teeth 5–12) in providing pulpal 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 studies with the FDA. St. Renatus completed Phase 1 clinical human trials in 2007, Phase 2 studies in January 2009, and 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 Meeting with the FDA on August 21, 2014. The FDA’s input regarding the company’s clinical trials and manufacturing data was very helpful to the St. Renatus team. The New Drug Application (NDA) was submitted to the FDA on May 29, 2015, and approved June 29, 2016.
Kovanaze is a major development for dental practitioners. For more than 100 years, dental anesthesia has been delivered through needle injections. We are excited to offer a needle-free method for delivering local anesthesia for restorative dental procedures. The approval, while based in science, was driven by our passion to enhance the dental experience for dentists and their patients.
When do you anticipate Kovanaze will be available to practitioners?
We anticipate having Kovanaze available this fall. Per FDA guidelines, our initial sales and marketing materials must be reviewed and approved for use before sharing this information. Our next milestones involve introducing Kovanaze to dental professionals, ensuring familiarity and proficiency with our product, and helping practitioners utilize this new technology to enhance patient comfort.
Tell us more about the sources of human and financial capital that have gone into building St. Renatus (i.e., how you’ve approached raising capital and attracting talented individuals to the team).
St. Renatus began through the support of family and friends that believed Kovanaze could become a reality. The networks of the founders and early investors allowed for the continuation and financial support of the drug development, while remaining privately held and under intended management. The St. Renatus team has doubled in size in the last year. The excitement of the product, its potential, and passionately driven team members have attracted the talent we need to bring Kovanaze into the dental community.
Without giving away any secrets, what does the future hold for the introduction of Kovanaze into the market (short- and /or long-term)?
Kovanaze launch efforts will involve ensuring that dental professionals have the necessary product information and training to feel comfortable offering Kovanaze to their patients. Using the dental dealer network, we will work with dentists to help them introduce this new technology for patient and practitioner benefit. We look forward to launching Kovanaze at the ADA Annual Meeting in Denver this October.
