Novalar Pharmaceuticals, Inc.
announced that results from two Phase 3 studies and a pediatric Phase 2
study of NV-101, a local dental anesthetic reversal agent, will be
presented at the 85th Annual Meeting of the International Association of
Dental Research (IADR) in New Orleans. John Yagiela, D.D.S., Ph.D.,
Professor and Chair, Diagnostic and Surgical Sciences at UCLA's School of
Dentistry will present data from the Phase 3 studies and Sharon Gordon,
D.D.S., M.P.H., Ph.D., Associate Professor, Department of Biomedical
Sciences and Brotman Facial Pain Center at the University of Maryland,
Baltimore, College of Dental Surgery, will present results from the
pediatric Phase 2 study.
The IADR is the largest and most prestigious organization for oral,
craniofacial and dental research with over 11,000 active individual members
worldwide. At the annual meeting, scientists communicate the latest peer
reviewed data to facilitate the rapid dissemination and application of
dental research findings.
Data from two Phase 3 studies shows that NV-101 was well tolerated,
safe, and met its primary and secondary endpoints. In both studies, NV-101
treated patients reported the return of sensation and function in less than
half the time it normally took after receiving local dental anesthesia.
NV-101 induced a 54.8 percent and a 62.3 percent decrease in time to normal
for those with anesthesia administered in the mandible and maxilla
respectively. These reductions were statistically different than control (p
< 0.0001) with no serious adverse events (SAE's) reported.
In the Phase 2 pediatric study for NV-101, the time to normal sensation
was reduced by 55.6 percent, a clinically and statistically significant (p
< 0.0001) acceleration of the return to normal sensation. As in the Phase 3
studies, NV-101 continued to be well tolerated with no SAE's reported in
the pediatric population studied.
"We were extremely pleased with the outcome of these studies, and we
are delighted that Dr. Yagiela and Dr. Gordon will unveil the results at
IADR, the most respected international dental research meeting," said Donna
Janson, President and Chief Executive Officer of Novalar. "Based on these
positive results, Novalar will continue to work closely with the U.S. Food
and Drug Administration (FDA) toward a successful submission of our New
Drug Application for NV-101 in the second quarter of 2007, and to build the
organizational infrastructure necessary to launch NV-101 following FDA
approval." If approved, NV-101 will be the only local anesthetic reversal
agent available for use in pediatric, adolescent and adult patients.
The two multi-center, randomized, blinded, controlled 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, including
adolescents and adults. In the first study, 244 patients received
anesthesia in the mandible (lower jaw) and in the second study, 240
patients were administered anesthesia in the maxilla (upper jaw). Following
anesthesia and completion of the dental procedure, patients were
administered either NV-101 or sham control.
"The fact that NV-101 met its endpoints so clearly, coupled with its
excellent safety profile, makes it a potentially useful treatment option
for the reversal of soft tissue anesthesia following routine dental
procedures," said Dr. Yagiela. "Its benefits are meaningful for both
dentists and patients."
Results from the Phase 2 pediatric, double blinded, controlled safety
study involving 11 study centers and 152 dental patients (aged 4-11)
complemented the Phase 3 results. In this study, the time to normal
sensation was reduced by a clinically and statistically significant (p <
0.0001) 55.6 percent. There were no SAE's and no subjects withdrew from the
study due to adverse events (AE's). No differences were apparent in the
frequencies or types of AE's reported by the two randomized treatment
groups. All AE's resolved by the end of the study observation period.
"Children are especially at risk from biting and chewing their cheeks,
tongues and lips when numb. The pediatric results for NV-101 provide
further evidence that this product could be safe and beneficial in this
patient population," added Dr. Gordon.
About NV-101
If approved by the FDA, NV-101 will be the only local anesthetic
reversal agent that accelerates the return to normal sensation and function
following restorative and periodontal maintenance procedures. The product
has been tested in pediatric, adolescent and adult patients. Phentolamine
mesylate (a vasodilator), the active ingredient in the investigational
agent NV-101, has been approved and in use in specific medical indications
at significantly higher doses for over 50 years.
About Novalar Pharmaceuticals, Inc.
San Diego-based Novalar Pharmaceuticals, Inc. is a privately held
specialty pharmaceutical company. The company's initial product offering,
NV-101, is being evaluated as a local anesthetic reversal agent and was
developed to rapidly reverse the lingering and debilitating lip and tongue
numbness associated with local dental anesthesia. For more information,
visit novalarpharm.
Novalar Pharmaceuticals, Inc.
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