St. Renatus LLC announced that the company had a
favorable End of Phase 2 review with the U.S. Food and Drug
Administration and will proceed with Phase 3 efficacy studies of its
nasal mist dental anesthetic in the near future.
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, according to the company.
"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, St. Renatus CEO.
Initial consumer research for the nasal mist product indicated that 90 percent of all patients were very likely or somewhat likely to choose the product over a needle-injected anesthetic.
Ninety-six percent of dentists surveyed said they expected to offer the nasal mist anesthetic when it becomes available, according to the company.
Phase 3 clinical studies required by the FDA are expected to be completed by the second half of 2011 with a new drug application likely to be filed in the latter part of 2011.
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, according to the company.
"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, St. Renatus CEO.
Initial consumer research for the nasal mist product indicated that 90 percent of all patients were very likely or somewhat likely to choose the product over a needle-injected anesthetic.
Ninety-six percent of dentists surveyed said they expected to offer the nasal mist anesthetic when it becomes available, according to the company.
Phase 3 clinical studies required by the FDA are expected to be completed by the second half of 2011 with a new drug application likely to be filed in the latter part of 2011.
