Onpharma’s Onset looks to benefit patients, doctors

Dr. Mic Falkel, Founder and Chief Medical Officer for Onpharma Inc., said the company’s new Onset anesthetic buffering products–launched at the Chicago Midwinter Meeting in February–were a long time coming and worth the wait. Dr. Falkel started developing the idea about 9 years ago in an effort to improve to the way anesthetic worked in his practice.

“I started down this road because I had challenges with local anesthetic that didn’t make sense to me. I had issues with anesthetic variability from patient to patient and even with the same patient from visit to visit,” he said. “I had been practicing for over 10 years. My dentistry had gotten very consistent and I was confident in my ability to provide excellent dental care and service to my patients, but still I could not take the uncertainty around anesthetic performance out of my practice day.”

Until he studied up and learned that many of his peers had the same frustrations, Dr. Falkel had thought maybe the problems he saw were the fault of his anesthetic technique. “Then I saw in the literature that a lot of dentists struggle with anesthetic success. In fact, we did our own meta-analysis of 36 published anesthetic success studies in dentistry, and I was shocked at how unreliable dental anesthetic seems to be. The problem is clearly not simply technique. The science says one fundamental problem is the acidic pH of the anesthetic cartridges we use.”

Dr. Falkel spent the next several years developing a process for buffering the pH of dentist’s existing dental anesthetic in the most simple and effective way he could envision–by raising the pH of a standard anesthetic cartridge from the equivalent of lemon juice to physiologic pH, just before the dentist loads it into the syringe and delivers the injection. This makes the injections more reliable and more comfortable.

“When it comes to injection comfort, basically I was taught in dental school that I could build my whole practice around delivering a comfortable injection, and my experience after 20 years in the business is that this was good advice. Survey after survey bears this out; Injection pain is the No. 1 thing that keeps people away from dentists and the way we’re most often graded by our patients.”

Like most experienced dentists, Dr. Falkel had ample opportunity to master his chosen injection techniques. “I was as good as I could be at giving a comfortable injection,” he said. But as Dr. Stanley Malamed explained, with some patients on some occasions, even the best-executed techniques don’t work. 

“I have spoken to a lot of dentists about the injection techniques they use,” the Onpharma founder said. “It’s really quite an art form and it’s quite interesting actually. There’s still that population of pH-sensitive patients where you do everything right and yet as that first drop of anesthetic goes in, they wince. I call that the ‘bee sting effect.’  That’s one of the places where Onset makes a big difference.”

The science also suggests that buffering reduces anesthetic onset time dramatically.

“Basically local anesthetic is packaged as an acid, but it doesn’t work as an acid in the body,” he said. “Essentially, when we inject patients with an anesthetic at the pH of lemon juice, we are asking their bodies to buffer the anesthetic solution to a much higher pH before it will begin to work. Now, with Onset, what we’re doing is buffering the anesthetic outside the body, in vitro, rather than waiting for the patient’s body to complete the same buffering process in vivo. 

“We’re taking the patient’s ability to buffer the anesthetic out of the equation for achieving analgesia. That’s a big deal.  Dentists have noted for years that patients who have had a lot of coffee, have not slept, or who had an active infection were harder to get numb. These are variables that effect the patient’s ability to buffer the anesthetic after it is injected.”

With Onset, we no longer ask the patient to do this work, he said, and their physiology is no longer the wild card in getting anesthetic to work.

“In my practice, the speed and reliability I get from buffering allows me to deliver the anesthetic, place the rubber dam, and go to work immediately without leaving the chair. I no longer get up, de-glove, exit the operatory and then return in 10 minutes to re-engage. My practice day has been shortened and my work flow is totally different. My patients feel like they are getting more of my attention because I don’t leave the operatory. For me, my staff, and my patients, buffering has been a game changer.”

Dr. Falkel also likes what he is hearing from customers. “Now that our product has been in the hands of dentists for several months, we know we made a good call using smart technology to turn the anesthetic cartridge already on the dentist’s shelf into its own perfect mixing vessel for buffering. We’ve created a practice-friendly 10-second chairside buffering process that our customers love,” he said. “We aren’t asking them to adopt a new type of anesthetic, a new delivery system, or even a new injection technique. We ask for 10 seconds to buffer the anesthetic cartridge. Our customers are happy to sacrifice those 10 seconds for the results they are getting.”

The indication for use for Onpharma’s buffering solution is to reduce injection pain for lidocaine and lidocaine with epinephrine.  Full prescribing information is available on the company’s website, www.onpharma.com, as are instructions for use for the Onset mixing pen and the Onset cartridge connectors, sold separately, that are used together to make the cartridge buffering process a snap.  

“When we created Onpharma six years ago, I hoped that one day dentists would be coming up to me and saying, ‘Mic, this is great, I wish I had thought of it.’ I hear that all the time now.”