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Video: Novalar Announces the Launch of OraVerse(TM) the First Dental Anesthesia Reversal Agent
Date:2/27/2009

and support clinicians in their efforts to provide outstanding patient care," stated Donna Janson, President and CEO of Novalar Pharmaceuticals. "The launch of OraVerse represents the culmination of years of effort from conception through commercialization. We look forward to translating the experience gained throughout the development of OraVerse to future innovative products in our portfolio."

OraVerse is approved by the U.S. Food and Drug Administration (FDA) as safe and effective for adults and children six years and older and weighing 33 lbs. or more. In clinical trials, patients that received OraVerse experienced a return to normal sensation and function in approximately half the time. The active ingredient in OraVerse is phentolamine mesylate, a drug used in other medical applications for the past 50 years.

OraVerse studies included three multicenter, double-blinded, randomized, controlled clinical trials. Two adult and adolescent trials were conducted with a total of 484 patients who had restorative or periodontal maintenance procedures and who had received one of four leading anesthetics that contained a vasoconstrictor. OraVerse reduced the median time to recovery of normal sensation in the lower lip by 85 minutes (55%), and in the upper lip by 83 minutes (62%) compared to control. In both maxillary and mandibular procedures, the median time to observed recovery of normal function was significantly reduced for patients receiving OraVerse (43% and 50% reduction respectively). The majority of adverse reactions were mild and resolved within 48 hours. There were no serious adverse reactions and no discontinuations due to adverse reactions.

In a pediatric trial with 152 patients, aged 4-11, OraVerse had no effect on adverse events, pain or post-treatment analgesic use, vital signs or oral mucosa. The median time to normal lip sensation in 115 patients 6 to 11 years of age who were trainable in the lip-palpatio
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