Dental Tribune USA

Novalar launches dental anaesthesia reversal agent

By Daniel Zimmermann, DTI
March 01, 2009

LEIPZIG, Germany: The US pharmaceutical company Novalar has launched their latest premier dental product OraVerse at the Chicago Midwinter Meeting held in Chicago in February. The product is the first local anaesthesia reversal agent that accelerates the return to normal sensation and function for patients who wish to avoid the lingering soft tissue anaesthesia following routine dental procedures in which a local anaesthetic containing a vasoconstrictor was used.

OraVerse was approved by the US Food and Drug Administration last year as safe and effective for adults and children six years and older and weighing 33 lbs. In two randomised, double-blinded, controlled Phase 3 studies, the agent reduced the median time to recovery of normal sensation in the lower and upper lip to approximately half the time compared to the control. Both studies were conducted on over 400 patients in 18 centres across the US.

“How to address soft tissue numbness is one of the most commonly asked questions in dentistry,” Dr Stanley Malamed, Professor of Anaesthesia & Medicine at the University of Southern California School of Dentistry, said. “OraVerse is the first solution of its kind that dentists can use to finally answer this question. It will provide dentists with a convenient alternative for completing routine dental procedures that allows patients to comfortably return to their daily routine”.

The active ingredient in OraVerse is phentolamine mesylate, a drug already used in other medical applications, such as the prevention or control of hypertensive episodes that may occur in patients with pheochromocytoma because of stress or manipulation during preoperative preparation and surgical excision. According to the company, OraVerse will come in a standard dental cartridge that can be easily injected utilising the same injection site and an identical technique to that of a local anaesthetic. It is used in a 1:1 ratio to local anaesthetic and has been tested in doses of 0.5, 1 and 2 cartridges.

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