�Novalar Pharmaceuticals, Inc., a
dental peculiarity pharmaceutical fellowship, announced the publication of three
clinical trials on the consumption of OraVerse (phentolamine mesylate) injection as
a local dental anaesthetic reversal agent in the August 2008 issue of the
Journal of the American Dental Association (JADA). The first publication,
entitled "Reversal of soft tissue paper local anaesthesia with phentolamine
mesylate in adolescents and adults" includes an overview of deuce pivotal
trials while the second publication "Reversal of soft-tissue local
anesthesia with phentolamine mesylate in pediatric patients" reviews the
paediatric Phase 2 data. Together these tonality Novalar-sponsored clinical
trials were the foundation for the FDA favourable reception of OraVerse in May 2008.
"JADA's publication of these trials highlights the importance and value
of these information to the dental community," commented Athena Papas, DMD, Ph.D.,
Professor at Tufts University School of Dental Medicine, Novalar Scientific
Advisor and joint author on both publications. "Many dental patients,
including children, could benefit from this clinical enquiry which establish
that OraVerse helped patients regain sentience to their lips and tongue in
approximately half the time following modus operandi dental procedures."
The first base publication inside information the efficacy and base hit of OraVerse in
reducing the duration of diffuse tissue anesthesia in patients receiving
touchstone local anaesthetic injections in two Phase 3 clinical trials. Median
recovery times in the lower brim and tongue were 70 and 60 minutes compared
with one hundred fifty-five and 125 minutes in the control group. Median recovery time in the
upper mouth was 50 minutes versus 133 transactions 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 age. No serious adverse events were reported in whatever of these
trials.
"We are very pleased with JADA's decision to print these studies,"
stated Donna Janson, President and Chief Executive Officer of Novalar. "As
the nation's premier dental daybook, publication in JADA farther
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 deliver 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 mouth and knife, and the associated functional deficits resulting from
an intraoral submucosal injection of a local anesthetic containing a
vasoconstrictive. OraVerse is not recommended for use in children less than
six years of long time or advisement less than 15 kg (33 lbs). Myocardial
infarct and cerebrovascular spasm and occlusion have been reported
following parenteral use of phentolamine, normally in association with
marked hypotensive episodes producing shock-like states. Tachycardia,
bradycardia, and cardiac arrhythmias may come about with the use of phentolamine
or other alpha-adrenergic blocking agents. Although such effects ar
uncommon with OraVerse (vasomax 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 pharmaceutic company that partners straight
with dental professionals to enrich the patient experience. The company is
uniquely positioned to develop targeted oral pharmaceutic products and
translate the full value of these novel solutions to clinical practice. For
more data, please visit http://www.novalar.com.
Novalar Pharmaceuticals, Inc.
http://www.novalar.com
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