Navigation Links
Journal of the American Dental Association Publishes Key Clinical Data for the Use of OraVerse(TM) a Local Anesthetic Reversal Agent
Date:8/12/2008

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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer
2. The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
3. Bioimpedance Spectroscopy is More Accurate and Reliable Than Other Methods of Subclinical Assessment of Lymphedema in Breast Cancer Patients, According to Paper Published in Journal of Clinical Oncology
4. Groundbreaking American Journal of Play from Strong National Museum of Play(R) Premiers July 2008
5. Journal of Clinical Oncology Publishes Study of Cephalon Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkins Lymphoma
6. Echo Therapeutics Announces Publication of Positive Clinical Data for its Symphony Transdermal Continuous Glucose Monitoring System in Journal of Diabetes Science and Technology
7. Complete Study Results Comparing CTIs OPAXIO(TM) With Gemcitabine or Vinorelbine in Performance Status (PS 2) NSCLC Patients Published in Journal of Thoracic Oncology
8. Results Published in the Journal Cancer Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma
9. Journal of Clinical Oncology Publishes Leukine(R) Study Demonstrating Positive Survival Outcomes in Patients with High-Risk Melanoma
10. Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)
11. The Foundation for Biomedical Research Announces Winners of the 7th Annual Michael E. DeBakey Journalism Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ... Antitrust Improvements Act of 1976, as amended ("HSR"), with ... ("Celator"; Nasdaq: CPXX ) expired effective June ... As previously announced on May 31, 2016, Jazz ... under which Jazz Pharmaceuticals has commenced a tender offer ...
(Date:6/24/2016)... June 24, 2016  Global Blood Therapeutics, Inc. (GBT) ... developing novel therapeutics for the treatment of grievous ... the closing of its previously announced underwritten public ... the public offering price of $18.75 per share. ... offered by GBT. GBT estimates net proceeds from ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... PASADENA, CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. ... he would lash out at his family verbally and physically. , “When something upset him, ... table, he would use it. He would throw rocks at my other children and say ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
Breaking Medicine News(10 mins):