|
|
|
|
 |
Novalar Receives FDA Approval for OraVerse |
| 5/12/2008 @ 6:18 AM
print this article -
email to a friend -
join our eNewsletter
|
 |
Novalar Pharmaceuticals, Inc., a dental specialty pharmaceutical company, announced today that the United States Food and Drug Administration (FDA) has granted marketing approval for OraVerse (phentolamine mesylate). OraVerse is the first pharmaceutical agent indicated for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. 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 Chief Executive Officer 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 pediatric dentists for use in patients over six years of age.
Over 300 million cartridges of local dental anesthetic are sold each year in the U.S. alone. Although widely used, it frequently results in unnecessary and lingering soft tissue anesthesia 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 anesthesia.
OraVerse's approval for use in adults and children is based on data from several clinical studies, including two Phase 3 studies in adults and adolescents age 12 and older and a Phase 2 pediatric study. The two Phase 3 studies were conducted in 18 centers 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 the randomized, double-blinded, controlled Phase 3 studies, following the administration of local anesthetics and completion of the dental procedure, patients were administered either OraVerse or control. OraVerse reduced the median time to recovery of normal sensation in the lower lip (as measured by standardized lip tapping procedures) by 85 minutes compared to control. OraVerse reduced the median time to recovery of normal sensation in the upper lip by 83 minutes. Within one hour after administration of OraVerse, 41% of patients reported normal lower lip sensation as compared to 7% in the control group, and 59% of patients in the OraVerse group reported normal upper lip sensation as compared to 12% in the control group. In both Phase 3 studies, the primary endpoint showed that OraVerse was statistically different compared to control (p<0.0001).
The multi-center, randomized, double-blinded, controlled Phase 2 pediatric study evaluated the safety and efficacy of OraVerse in the reversal of soft tissue anesthesia in patients undergoing dental procedures after receiving local anesthetic. This study enrolled 152 patients: 96 patients in the OraVerse group and 56 patients in the control group. Of the 152 patients enrolled, 115 were trainable in the assessment method: 72 patients in the OraVerse group and 43 patients in the control group. The study assessed OraVerse's efficacy through the measurement of time to normal lip sensation for those trainable in the assessment. The median time to normal sensation in patients age 6-11 was reduced by 75 minutes for the OraVerse treated group, a 56% acceleration of the time to normal sensation.
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."
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).
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 www.novalarpharm.com/. |
| BioTech / BioMedical / Medical |
|
|
| |
| Tuesday, July 8, 2008 |
 |
|
International Stem Cell Corporation Announces Collaboration with Michigan State University to Study Parthenogenetic Stem Cells Posted 7:47 AM PST
FDA Grants Invitrogen Premarket Approval of Breast Cancer Test Posted 7:42 AM PST
|
| |
| Monday, July 7, 2008 |
|
|
Anadys Pharmaceuticals Resumes Clinical Investigation of TLR7 Mechanism in HCV Posted 3:06 PM PST
AutoGenomics INFINITI Analyzer Receives Artistic Design Award Posted 6:35 AM PST
|
| |
| Wednesday, July 2, 2008 |
|
|
PainReform Licenses a Novel Sustained Release Formulation of Ropivacaine from Encore Therapeutics Inc. Posted 6:37 AM PST
Sequenom Launches iSEQ Application Posted 6:36 AM PST
Sequenom Announces Exercise in Full of Underwriters’ Option to Purchase Additional Shares Posted 6:36 AM PST
PURE Bioscience Strengthens Pharmaceutical Development Program Posted 6:33 AM PST
MicroIslet Provides Safety and Efficacy Data Update; No Adverse Events Attributable To MicroIslet-P In Animal Models Posted 6:31 AM PST
|
| |
| Tuesday, July 1, 2008 |
|
|
Metabasis to Present at the Collins Stewart 4th Annual Growth Conference Posted 4:34 PM PST
ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor Posted 1:35 PM PST
The Wellcome Trust Case Control Consortium (WTCCC) Selects Illumina Infinium High-Density (HD) DNA Analysis Products to Study 90,000 Samples Posted 8:04 AM PST
Aethlon Medical Announces Second HIV/AIDS Treatment Site Posted 8:03 AM PST
|
| |
| Monday, June 30, 2008 |
|
|
Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial Posted 3:11 PM PST
Invitrogen and the Génome Québec and Montreal Heart Institute Pharmacogenomics Centre Announce Collaboration to Advance Pharmacogenomics Research Posted 2:52 PM PST
Burnham Institute Researchers Link Early Stem Cell Mutation to Autism Posted 2:51 PM PST
SGX Pharmaceuticals Submits Investigational New Drug Application for SGX393 Posted 6:46 AM PST
Cardium Announces Follow-On Direct Investment by Institutional Investor Posted 6:41 AM PST
Early Results from Ongoing Clinical Study of Hepatitis C Vaccine Delivered by Inovio Biomedical’s Electroporation System Show Increased T-Cell Responses and Reduced Viral Loads Posted 6:31 AM PST
|
| |
| Wednesday, June 25, 2008 |
|
|
$6 Million Grant from NIH Advances Vical RapidResponse DNA Vaccine Platform Posted 8:55 AM PST
Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing Posted 8:49 AM PST
Mpex Initiates a Phase 2 Clinical Trial of Aerosol MP-376 in the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients Posted 8:49 AM PST
International Stem Cell Corporation Cuts a Deal with BioTime, Inc., and Embryome Sciences, Inc., to Provide Unique Human Stem Cell Lines for Research Use Posted 8:08 AM PST
|
|
|
|
|
|
FreshNews.com Jobs Change DAILY
We Have 5,000 + Job Listings! Open Your FREE Account
Employers or Job Searchers Get Started Now! Click Here
|
