Patients soon may turn up noses at dental pain

Sliding into the dentist chair for an oral procedure soon might become less daunting thanks to a Fort Collins-based biopharmaceutical company.

St. Renatus LLC hopes to make needles a thing of the past by creating a dental anesthetic spray administered through the nasal cavity. The company completed both the

Adult and Pediatric Phase 3 clinical trials this year and plans to submit the new drug application to the U.S. Food and Drug Administration in the first half of 2014.

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St. Renatus filed its first patent in 2000. Thirteen years after that initial filing, the final phase of testing by the FDA has been completed.

“It can take anywhere between 10 to 12 years to develop a new technology and take it through all the clinical trials to get it to the market,´ said April Giles, president and chief executive of the Colorado Bioscience Association. “About 80 percent of Phase 3 trials fail, so the fact that they completed the Phase 3 trial is a huge accomplishment.”

According to Jill Shoemaker, vice president for investor relations, St. Renatus has initiated a human factors process, which tests the usability of the product instructions by dental professionals.

“We’re also working on our new drug application, which we plan to submit to the FDA in the second quarter of next year,” she said. “We anticipate having FDA approval six to 10 months upon our NDA submission.”

Upon FDA approval, St. Renatus intends to package the product in a ready-to-use and disposable nasal spray device.

Giles said it’s not unusual for the development and testing process to take longer than anticipated.

“It’s pretty common when dealing with science to have challenges along the path that need to be addressed before it can move forward,” she said.

The nasal spray is designed for use on the upper mouth. The anesthetic works to numb the maxillary nerve, which controls sensation in the roof of the mouth, including teeth. Patients needing procedures such as fillings and crown preparation potentially could be given the nasal spray instead of anesthetic injections.

A St. Renatus consumer research report indicated that 90 percent of dental patients said they were “very likely or somewhat likely” to choose the nasal mist product over a needle-injected anesthetic, and 96 percent of dentists surveyed said they would offer the nasal mist anesthetic when it becomes available.

The impact of St. Renatus’ success on the Fort Collins bioscience sector is expected to be significant, Giles said. About 80 percent of bioscience companies in Northern Colorado are in the product-development stage, with only 20 percent of them either going to market with their products or already on the market.

“This is huge for Colorado as a whole, as well as Northern Colorado, for a company to have completed all of their clinical work and bring a product to the market,” she said. “It’s a significant milestone.”

According to the St. Renatus 2013 Executive Summary Report, approximately 250 million doses of dental anesthetics are sold annually in the United States alone. It is estimated that 40 percent of those procedures could qualify for the nasal mist product.

Worldwide, more than 2.5 billion doses of dental anesthesia are delivered each year.