Tuesday, November 18, 2008

Oraverse - The Reverse Dental Anesthesia Drug to Be Introduced in February 2009


Oraverse - The Un-Numb Drug for Dentistry

A new drug to un-numb patients after dental anesthesia will be introduced in February at the Chicago Mid-Winter meeting.

Novalar is aiming to tap into this trend with phentolamine mesylate (Oraverse). It’s pretty simple. Most dental anesthesia uses a vasoconstrictor, which limits blood flow to the tissues in the mouth around the teeth. The Novalar drug is a vasodilator, which allows the blood flow to return to the gums, lips and cheeks.

The company got started in 2000, when Eckhard Weber of Domain Associates worked on a project to see if this vasodilator could be turned from a powder form into a low-dose, stable liquid injection which could be used to reverse lingering anesthesia. It worked, passed a clinical trial in 418 patients, and was approved by the FDA in May. The drug reduced the median time to recovery of normal sensation in the lower lip by 85 minutes compared with those in a control group.

The product is sold in a cartridge that fits into a standard dental syringe, and is injected while the patient’s mouth is already numb, Janson says. It plans to sell the cartridge for about $12.50 a shot.
Flap sees a limited applicability for this drug since the mandibular block most associated with lower lip and tongue numbness is growing out of favor for most routine dental procedures anyway. Plus, there are some shorter acting dental anesthetics that can be used as well.

However, there are some patients who will have extensive procedures who may wish to return their soft tissues to normal quicker - e.g business. On the other hand, increased duration of anesthesia is desirable for patient comfort.

Flap bets the drug will be marketed for use in children over the age of 6 or 7 and adolescents so they will not have an opportunity to chew their lip.

Novalar has hit one bump in the road this year. When it got FDA approval, it planned to introduce the product at the American Dental Association’s meeting in October in San Antonio. They missed that deadline after it had a packaging problem that didn’t meet quality standards, Janson says. Now it plans to introduce the drug at a dental meeting in Chicago in February.

Novalar doesn’t have any direct competitors in this market, so it’s preparing as if the opportunity is its for the taking. The company has 30 employees now, up from just nine a year ago. It is hiring aggressively, building its staff to 55 by year-end, and close to 100 by August, many of them in sales jobs. The product will be rolled out regionally in places that demand cosmetic dentistry, like urban areas of California, Illinois, Florida, New York, Texas, and Baltimore, Janson says.
Stay tuned........

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1 comment:

  1. Anonymous12:36 PM

    This could turn out to be a very good product. It will probably end up being used in cosmetic dentistry offices like that of Dr. Bagai in Chicago. I would not be surprised if they included some information on this product on their website, www.drbagai.com, once it is released and starts being used.