Anesthetic Reversal Agent
Here is something I did not know about. As per members of the Internet Dental Forum
there is a strong likelihood a local anesthetic reversal agent will be available in the USA sometime in 2nd quarter of 2008.
Just an FYI for all of us who were unaware of this.
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.
there is a strong likelihood a local anesthetic reversal agent will be available in the USA sometime in 2nd quarter of 2008.
Just an FYI for all of us who were unaware of this.
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.
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