Novalar Pharmaceuticals, Inc., a dental specialty pharmaceutical company, announced that the United States Food and Drug Administration (FDA) has granted marketing approval for OraVerse (phentolamine mesylate).
OraVerse is the pharmaceutical agent indicated for the reversal of softtissue anaesthesia and the associated functional deficits resulting from a local dental aesthetic. Novalar is establishing a specialty direct sales force to launch OraVerse in late 2008.
"The approval of OraVerse is the result of the outstanding efforts of our development team, our strong collaboration with the FDA and our focus and commitment to realizing the vision of our founder, Dr Eckard Weber. This first-in-class therapeutic will provide dental professionals with a novel solution to enhance the overall experience for their patients," stated Donna Janson, president and CEO of Novalar.
Novalar plans to launch OraVerse at this year's American Dental Association (ADA) Annual Session being held in San Antonio, Texas from October 16-20, 2008. Novalar's sales force will focus on general and paediatric dentists for use in patients over six years of age.
Over 300 million cartridges of local dental aesthetic are sold each year in the US alone. Although widely used, it frequently results in unnecessary and lingering soft tissue anaesthesia and associated functional deficits. Novalar's market research with both patients and dentists has indicated strong interest in a product that will reduce the time to normal sensation and function following local dental anaesthesia. OraVerse's approval for use in adults and children is based on data from several clinical studies, including two phase III studies in adults and adolescents age 12 and older and a phase II paediatric study. The two phase III studies were conducted in 18 centres across the United States, including leading dental schools, clinical research organizations and private clinics. There were 484 dental patients enrolled across the two studies.
In all OraVerse clinical trials, there were no serious adverse events reported and the most common adverse reaction that was greater than control was transient injection site pain. Although tachycardia and cardiac arrhythmia may occur with the parenteral use of alpha-adrenergic blocking agents, such events are uncommon after submucosal administration of OraVerse.
"The Novalar team is extremely excited to bring to market a first-in-class product with such strong interest from both patients and dentists," added Ms. Janson. "It is seldom that a company is able to conceive, develop and market such an innovative product that has the ability to change the standard of care in dentistry. Novalar is committed to making OraVerse a commercial success and believes we are well positioned to bring additional dental pharmaceuticals to market through our unique development capabilities".