Breakthrough Dental Anesthesia Reversal Drug Introduced

A new medication has just been released to reverse the much disliked numbness after dental visits. Injected into the numb area it reduces the time you are numb by 50% or more. Dentists and patients are excited to have this option available.

Encino, CA (PRWEB) May 5, 2009 -- Have you bitten your lip or tongue and talked like you are drunk after a shot of Novocain. Most of us would say yes without hesitation. Actually, it wasn't Novocain, but the shot and the after effects are still the most disliked part of a visit to the dentist. Novocain shots became obsolete in the 1950's. It has become a part of the dental history books. Novocain was replaced by the much more effective lidocaine over 50 years ago. About 300 million injections of local anesthetics are given in the United States each year in medicine and dentistry. A very effective nerve blocker, lidocaine is used for a vast range of procedures from childbirth pain, to dental treatment and is universally accepted as safe with a very low incidence of allergies. That said, most people still hate it after it is needed. It is like a love/hate relationship.

Now, at long last, there is a medication that reverses the numbing effects of local anesthetics. Called OraVerse®, it was developed by Novalar Corp., and is the first and only dental anesthetic reversal agent to receive FDA approval. The trials at Tufts University in Boston, UCLA in Los Angeles, and the University of Pennsylvania in Pittsburgh found a reduction of approximately 50% in the time it takes for the numbing agents to wear off according to the studies. In tests, dentists using the product in their offices in pre-release trials saw great acceptance from their patients. Many dentists believe that even better results are possible as experience in its use grows.

Dentists are very excited about the potential for this new option for their patients

OraVerse® would be especially helpful for children, the elderly and special needs patients, who are more prone to bite their lip or tongue during the time their mouth is numb. Everyone has been waiting for this for a long, long time. I am very pleased to be able to offer my patients this great advance. It is a real breakthrough.

Friends often find this a great time to do a lot of teasing. With their lip drooping, face sagging, and talking with a slur is not a pretty sight

In the interview, Dr. Melnick said "OraVerse® would be especially helpful for children, the elderly and special needs patients, who are more prone to bite their lip or tongue during the time their mouth is numb. Everyone has been waiting for this for a long, long time. I am very pleased to be able to offer my patients this great advance. It is a real breakthrough."

The FDA approval was based on four clinical trials, including three trials that involved adolescents and one involved children as young as 6. The evidence was conclusive that this is a safe product.

Most patients hate to go back to their offices numb and then explaining what has happened to them. "Friends often find this a great time to do a lot of teasing. With their lip drooping, face sagging, and talking with a slur is not a pretty sight" said Dr. Melnick, formally on the faculty of UCLA and very knowledgeable about local anesthetics.

Another advantage to OraVerse® is that the dentist can perform procedures on both sides of the mouth during one visit, rather than requiring two visits. There are lots of areas where OraVerse could really make a difference in time and convenience and make people much more comfortable following the treatment. Procedures on two sides of the mouth are very uncomfortable because of the complete loss of sensation on both sides at the same time and a loss of control of the numb areas.

Long desired by dentists and patients, OraVerse was no easy product to develop and bring to market. There is an additive called Epinephrine in many dental anesthetics. It keeps the drug in the body long enough to complete the procedure. That additive works by constricting the blood vessels in the area to also make the anesthetic more effective. Also called adrenaline, it is a natural substance produced by the adrenal glands to prepare the body for emergency situations. Many people remember epinephrine from high school as the "fight or flight" inducing agent produced in the body.

I had a though that the numbness might be something that could be reversed, said the developer, James Weber, M.D.

Dr. Weber and a group of scientists researched drugs that reverse the restriction of blood flow that is caused by the epinephrine. It was found that a common drug for medical uses called phentolamine would be a suitable candidate for trials. It has been used for over 45 years and has blood flow improving action, reversing the effects of epinephrine. Remarkably, phentolamine has few known side effects in dental doses, according to many reports.

Dr. Weber and his associate Dr.Katz patented phentolamine mesylate for dental anesthesia reversal. And in 2001, Drawbar Company founded Novalar Corp. to prepare the product to market.

Dr. Weber gathered a group of scientists to develop a way to formulate phentolamine for dental use. Finding a proper does and in a liquid form that could be put into a cartridge for the same syringe that dentists use to inject anesthesia was the goal. It was felt that having OraVerse® in a form that dentists were very familiar with would encourage its use.

It took three years, until April 2007, before Novolar had the clinical trials it needed to submit to the FDA. To receive approval from the FDA for a new medication is not easy. The company had to demonstrate effectiveness, usefulness, and reliability for its new anesthesia reversal product. The FDA reviewed the data for years and finally gave its approval just recently.

The developers made market research that shows that there was a demand. In a survey of consumers and dentists, hundreds of the consumers and ¾ of the dentists said they would like such a product, and thought it was great to have available.

Some Patients were concerned whether pain would return as soon as the numbness was gone. The studies did not show pain to be any more or less with the use of OraVerse®. Some dentists like to give their patients a dose of a pain medication such as Ibuprophen at the beginning of a procedure so there is no worry about postoperative pain. Dr. Melnick (www.FocusedCareDental.com) said that his preference is a medication called Clinoral which he has found in his general practice to be much more effective in almost all cases with few side effects. This again is the adaption of a medically used drug for dental care.

OraVerse® is made in San Diego by Novalar, Inc. in a new state of the art facility and OraVerse® is now available and used some advanced, cutting edge dental offices.

www.FocusedCareDental.com

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