Company seeks to end needle pain in dentistry

FORT COLLINS – St. Renatus CEO Steve Merrick is spending a lot of time on the road these days, seeking to interest potential investors in a new drug that he says will revolutionize dentistry.

The Fort Collins-based startup is working to get final FDA approval for “the world’s first needle-free dental anesthetic administered through the nasal cavity,” according to the St. Renatus website.

That’s right – a dental anesthetic that’s misted into the nose.

And that’s something many needle-fearing adults and probably most kids would be very interested in trying when they sit down in that dentist’s chair, Merrick said.

“When this drug is proven effective, it will provide a better way to handle pain in dentistry,” he said. “That’s my mantra: This is absolutely something that will revolutionize the whole concept of dental pain and gets rid of the phobias that go with needles.”

According to St. Renatus’ consumer research, 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 road to FDA approval has already been a long one. The first patent for the drug was filed in 2000, and was awarded in 2002. It took another five years to complete the first phase of safety studies and two more to complete Phase 2 efficacy studies.

Merrick, formerly the vice president for global marketing for Septodont – a world leader in injectable anesthetics – was hired in September 2009 to help St. Renatus get its product across the FDA goal line.

Nearly two years later, the drug is about to enter the final phase of efficacy studies. Merrick said the company is about to begin a 60-patient, three-week study in June that will set the stage for large-scale studies expected to begin by mid-July or early August.

“We want to make sure our data is very strong before we start large-scale studies,” Merrick said.

In those large-scale studies, more than 300 patients will be tested in dental schools across the nation, including some as young as three years old.

The product has one large caveat: Initially, it will only anesthetize upper teeth.

“Sometimes it’s easier to take these tools in steps,´ said Merrick. “We know we have a very effective formula for upper teeth with 100 percent efficacy, but when you move to other areas of the mouth we don’t get the same efficacy.”

But getting away from needles in dental work performed in the upper teeth is a good start, he noted.

“The roof of the mouth is one of the most painful areas to inject,” Merrick said, adding that research is continuing on a needle-free anesthetic for the entire mouth.

Merrick said the notion of topical anesthetics is not a new one, but added “none have tried to give total anesthesia to the top teeth.”

“The drug is unique in that it anesthetizes the pulp of the tooth so you can drill it, and we’re doing our research to prove that point,” he said.

Merrick said the road to final FDA approval, which he hopes will be secured in 2012, has also been an expensive one. More than $25 million has been invested in the product so far “and we’re not done,” he added. “Fundraising is an ongoing process.”

But Merrick says he’s confident that the long and expensive journey will be worth it.

“In the U.S. alone, there are roughly 125 million injections into the top part of the mouth every year,” he said. “I believe there’s going to be a strong demand for the drug once we get our approval. I think it will be a very fruitful experience when it’s over.”

Steve Porter covers health care for the Northern Colorado Business Report. He can be reached at 970-232-3147 or at sporter@ncbr.com.

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