FDA clears anaesthetic-reversing drug

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In trials, OraVerse was found to halve the recovery time of numbed patients.

The US Food and Drug Administration (FDA) has given the green light to the first dental anaesthesia reversal agent.

OraVerse (phentolamine mesylate injection) has been found to reverse soft-tissue anaesthesia from agents such as Novocaine in half the time it usually takes for numbing agents to subside.

Marketed by San Diego pharmaceutical company Novalar, OraVerse is the brainchild of dentist Howard Katz and Dr Eckard Weber, the founder of several biotechnology companies.

At the close of a dental procedure, the agent is injected into the site of the anaesthetic. Dr Paul A Moore, chairman of anaesthesiology at the University of Pittsburgh School of Dental Medicine and an adviser to Novalar, said the drug reverses the effects of epinephrine, an additive that is widely used to extend the effects of numbing agents.

While epinephrine constricts blood vessels to slow the dissipation of the anaesthetic into the bloodstream, phentolamine opens up the blood vessels to increase blood flow.

In clinical trials, OraVerse cut the median recovery time to normal sensation in the lower lip by 85 minutes and in the upper lip by 83 minutes, when compared to control.

One hour after OraVerse use, 41% of patients reported normal lower lip sensation compared to 7% in the control group. Fifty-nine percent of patients in the OraVerse group reported normal upper lip sensation, compared to 12% in the control group.

Dentists who participated in the trials said the drug will allow procedures to be performed on both sides of a patient's mouth during a single visit.

The agent is also expected to be particularly useful for children, the elderly and special needs patients who are more likely to bite their lip or tongue when numbed.

Novalar's chief executive Donna Janson said the company has carried out extensive market research to determine the demand for the drug.

Polls showed that, of the 253 consumers and 296 dentists surveyed, 87 and 85% respectively said they would be interested in the product.

Novalar plans to begin selling OraVerse in October, though pricing has not yet been confirmed.

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