Nasal mist

JADA 2012

St. Renatus's nasal mist is the world’s first dental anesthetic administered through the nasal cavity and suitable for use in hard tissue (i.e., tooth) procedures involving most of the upper teeth (e.g., fillings, crowns, bridges, root canals, etc.). The mist, unlike traditional shots used in numbing the teeth, is sprayed into the nasal cavity, anesthetizing only the upper teeth and not the patient’s lips and face.

The objectives behind the drug include:

Creating a drug to reduce the risk of blood borne disease for the patient and dental office staff
Reducing the fear and anxiety of patients needing dental procedures involving the upper teeth by eliminating the needle
The FDA approval process
St. Renatus’ nasal mist has undergone Phase 1 and Phase 2 clinical trials of the U.S. Food and Drug Administration (FDA) process at the SUNY Buffalo Dental School. The FDA Phase 2 trials’ initial results indicated 90-percent efficacy which is equal to needle injection results. Pharmacokinetics (PK)/safety study was completed in the fall 2010 at *The University of Pennsylvania School of Dental Medicine. Initial results following the tests indicated the nasal mist to be safe and effective, as observed in Phase 2 live dentistry trials.

Subject to the completion of the Phase 2 meeting with the FDA and its review of our Phase 3 protocol, St. Renatus anticipates initiating Phase 3 clinical studies, which will study efficacy and final formulation in the first quarter of 2012. Phase 3 clinical studies and other preclinical testing required by the FDA are expected to be completed in the second quarter of 2012. St. Renatus expects to submit the New Drug Application (NDA) to the FDA promptly after completion of Phase 3 studies.

*The University of Pennsylvania School of Dental Medicine also submitted an article to The Journal of the American Dental Association (JADA) discussing the PK study. The paper is estimated to be published in early 2012

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