SAN DIEGO, Aug. 12 CA-Novalar-OraVerse
SAN DIEGO, Aug. 12 /PRNewswire/ -- Novalar Pharmaceuticals, Inc., a dental
specialty pharmaceutical company, announced the publication of three clinical
trials on the use of OraVerse (phentolamine mesylate) injection as a local
dental anesthetic reversal agent in the August 2008 issue of the Journal of
the American Dental Association (JADA). The first publication, entitled
"Reversal of soft tissue local anesthesia with phentolamine mesylate in
adolescents and adults" includes an overview of two pivotal trials while the
second publication "Reversal of soft-tissue local anesthesia with phentolamine
mesylate in pediatric patients" reviews the pediatric Phase 2 data. Together
these key Novalar-sponsored clinical trials were the foundation for the FDA
approval of OraVerse in May 2008.
"JADA's publication of these trials highlights the importance and value of
these data to the dental community," commented Athena Papas, DMD, Ph.D.,
Professor at Tufts University School of Dental Medicine, Novalar Scientific
Advisor and co-author on both publications. "Many dental patients, including
children, could benefit from this clinical research which found that OraVerse
helped patients regain sensation to their lips and tongue in approximately
half the time following routine dental procedures."
The first publication details the efficacy and safety of OraVerse in
reducing the duration of soft tissue anesthesia in patients receiving standard
local anesthetic injections in two Phase 3 clinical trials. Median recovery
times in the lower lip and tongue were 70 and 60 minutes compared with 155 and
125 minutes in the control group. Median recovery time in the upper lip was 50
minutes versus 133 minutes in the control. The second publication evaluated
the safety of OraVerse in children aged 4 to 11 years following a dental
procedure and the efficacy and safety of OraVerse to accelerate the reversal
of soft-tissue local anesthesia in children aged 6 to 11 years. No serious
adverse events were reported in any of these trials.
"We are very pleased with JADA's decision to publish these studies,"
stated Donna Janson, President and Chief Executive Officer of Novalar. "As the
nation's premier dental journal, publication in JADA further demonstrates the
quality of our clinical science and allows Novalar the opportunity to begin
educating the dental community on the benefits of OraVerse to both patients
and clinicians."
About OraVerse
OraVerse (phentolamine mesylate) Injection is the only local anesthetic
reversal agent that accelerates the return to normal sensation and function
following restorative and periodontal maintenance procedures. OraVerse is
indicated for the reversal of soft-tissue anesthesia, i.e., anesthesia of the
lip and tongue, and the associated functional deficits resulting from an
intraoral submucosal injection of a local anesthetic containing a
vasoconstrictor. OraVerse is not recommended for use in children less than six
years of age or weighing less than 15 kg (33 lbs). Myocardial infarction and
cerebrovascular spasm and occlusion have been reported following parenteral
use of phentolamine, usually in association with marked hypotensive episodes
producing shock-like states. Tachycardia, bradycardia, and cardiac arrhythmias
may occur with the use of phentolamine or other alpha-adrenergic blocking
agents. Although such effects are uncommon with OraVerse (phentolamine
mesylate), clinicians should be alert to the signs and symptoms of these
events, particularly in patients with a history of cardiovascular disease.
About Novalar
Novalar is a specialty pharmaceutical company that partners directly with
dental professionals to enrich the patient experience. The company is uniquely
positioned to develop targeted oral pharmaceutical products and translate the
full value of these novel solutions to clinical practice. For more
information, please visit http://www.novalar.com.
SOURCE Novalar Pharmaceuticals, Inc.
