St. Renatus, LLC, With Guidance From The U.S. Food And Drug Administration, Has Established Readiness To Proceed To Phase 3 Trials
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St. Renatus and the FDA discussed details for both Phase 3 Adult and Pediatric studies to be conducted in the near future. Final revised protocols will be forwarded to the FDA in the coming weeks.
The Phase 2 clinical trial results submitted to the FDA indicated that the nasal mist is comparable to that of a standard needle-injected dental anesthetic.
“We are very pleased with how the nasal mist has performed in trials thus far,and with the outcome of our meetings with the FDA. We believe it represents a significant step forward for both St. Renatus and the field of Dentistry,” said Steve Merrick, Chief Executive Officer for St. Renatus, LLC.
Initial consumer research for the nasal mist product found that if patients are given the choice between a nasal mist anesthetic and a needle-injected anesthetic, 90 percent of all patients are very or somewhat likely to choose the new product, and 23 percent are very likely to switch to a dentist offering the nasal spray option.(1)
96% of dentists surveyed expect to offer the new nasal mist anesthetic to their patients.(1)
Phase 3 clinical studies required by the FDA are expected to be completed in the second half of 2011. A New Drug Application will likely be filed in the latter part of 2011.
(1) Research conducted by Industrial Research Center, Glen Mills, PA. February, 2011.
Source: St. Renatus, LLC