Pierrel Research USA, a subsidiary of Pierrel SpA, will officially launch its new Orabloc articaine product in the U.S. at the California Dental Association (CDA) spring meeting in Anaheim this week.
Orabloc is a purer formulation of articaine with epinephrine, the company explained in a press release.
"Up to this point, all available U.S. brands of articaine are manufactured in Canada using the terminal sterilization method," said Canio Mazzaro, chairman and CEO of Pierrel SpA. "Pierrel manufactures Orabloc using an aseptic method in our [U.S. Food and Drug Administration (FDA)-approved] facility in Capua, Italy, and the result is a purer formulation of articaine."
This means Orabloc has less degradation and fewer impurities, such as articaine acid and epinephrine sulphonic acid, he added. It also requires less overage of epinephrine, so there is less vasoconstrictor in each injection, he noted.
"Orabloc is not only the first aseptically manufactured articaine available in the U.S., it is one of the few Italian pharmaceutical products approved by the FDA in the last 30 years," Mazzaro said.
Orabloc offers the same rapid onset of action that dentists expect from existing articaine products: anesthesia within one to nine minutes, with complete anesthesia lasting about one hour for infiltrations and up to two hours for nerve block, according to Bernardo Verrengia, scientific and regulatory advisor for Pierrel SpA.
"Additionally, our aseptic manufacturing process provides significantly increased shelf life for Orabloc -- up to 24 months at 25° C (77° F), compared to 18 months shelf life for terminally sterilized articaine," Verrengia said.
In addition to the U.S., Orabloc has marketing approval in Canada, Italy, and Russia, with approvals pending in Germany, the U.K., France, Austria, and Poland.
It will be available in the U.S. through Patterson Dental.
