Adamas Pharmaceuticals Presents New Traumatic Brain Injury Data From Its
Nurelin™ Program At American Academy Of Neurology Conference
EMERYVILLE, Calif., March 20, 2013
EMERYVILLE, Calif., March 20, 2013 /PRNewswire/--Adamas Pharmaceuticals, Inc.
will present research results today from its Nurelin^TM (amantadine HCl
extended release capsules) program demonstrating the benefit of amantadine in
traumatic brain injury (TBI) at the 65^th American Academy of Neurology (AAN)
Annual Meeting being held in San Diego, CA. Nurelin, a once-daily extended
release formulation of amantadine intended for nighttime administration, is
being evaluated in a Phase 2/3 clinical study for the treatment of
levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) patients.
Adamas is currently investigating the activity of amantadine in preclinical
models for other central nervous system (CNS) disorders, and anticipates
identifying up to two additional indications for development.
"The results presented today are the first from several research studies
demonstrating additional therapeutic applications for Nurelin beyond our
initial indication for the treatment of LID in Parkinson's disease," said
Gregory T. Went, Ph.D., Chief Executive Officer of Adamas. "Our data
presented at AAN data show a statistically significant dose response for
amantadine in the improvements in cognition in a murine model of moderate
traumatic injury. A significant reduction in neuronal cell death was also
observed. This is the first time this preclinical model has been validated
with a drug that has shown a benefit in recent human clinical studies."
Amantadine has demonstrated clinical benefit in the treatment of human
traumatic brain injury in previously published studies in sub-acute and
chronic TBI. With this as a starting point, Adamas researchers initially
determined a dosing regimen in a preclinical model that produced steady state
drug plasma exposures similar to Nurelin in humans. Following moderate
percussion injury and treatment with amantadine, animals were evaluated for
spatial learning and memory performance. Using clinically relevant drug
exposures, amantadine produced significant improvement in cognitive
performance and inhibition of neuronal cell death after experimental TBI.
These results support the further evaluation of amantadine for the treatment
of symptoms of TBI for which there is currently no approved therapeutic
These data are being presented during the Neurocritical Care session today at
5:30 pm PDT in a poster titled: Amantadine Improves Cognitive Outcome after
Fluid Percussion Traumatic Brain Injury in Rats (Abstract PS5.209).
About Nurelin (ADS-5102)
Nurelin (ADS-5102) is a proprietary formulation of amantadine in development
for the treatment of central nervous system (CNS) disorders, including LID in
PD patients. Nurelin is designed for once-daily administration at night and
is being investigated at plasma concentrations up to 2.5 fold higher than
those achievable with the commercially available immediate-release amantadine
tablets. Nurelin has a pharmacokinetic profile designed to reduce the CNS
side effects associated with immediate release forms of amantadine, while
offering potential for enhanced efficacy. This novel pharmacokinetic profile
of Nurelin is characterized by: i) higher plasma concentrations during the
daytime hours when the motor and non-motor symptoms of Parkinson's disease are
at their peak; ii) low plasma concentrations overnight, which may reduce sleep
disturbance and vivid dreams occasionally associated with amantadine; and iii)
a reduced initial rate of rise in plasma concentration, which is expected to
improve overall CNS tolerability of amantadine. The efficacy and tolerability
of multiple doses of Nurelin in the treatment of LID in Parkinson's disease
patients is currently being studied in a Phase 2/3 study. This study,
entitled EASED (Extended Release Amantadine Safety and Efficacy Study in
Levodopa-Induced Dyskinesia), is designed to evaluate the efficacy of three
dose strengths of Nurelin for the treatment of LID, and to confirm
tolerability and dosing. Additional information about this trial may be found
About Traumatic Brain Injury (TBI)
Traumatic brain injury occurs when a sudden trauma disrupts the normal
function of the brain. According to the Centers for Disease Control and
Prevention at least 1.7 million people experience a TBI each year and the vast
majority of these result in concussion. Traumatic brain injury represents a
serious public health problem in the US for which there is currently no
approved therapeutic treatment.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals is a leading developer of aminoadamantane-based
therapeutics. The Company's products are designed to provide improved
tolerability, efficacy and dosing for the treatment of CNS disorders including
Alzheimer's disease, Parkinson's disease and Traumatic Brain Injury (TBI).
Adamas' three lead product candidates include MDX-8704 (memantine HCl
ER/donepezil, US market) and ADS-8704 (memantine HCl ER/donepezil, ex-US), the
first potential fixed dose combination drug treatments for Alzheimer's
disease, and Nurelin™ (ADS-5102) the first potential drug for the treatment of
levodopa-induced dyskinesia in Parkinson's disease.In November 2012, Adamas
entered into an agreement with Forest Laboratories for the late-stage
development and commercialization of MDX-8704 (memantine HCl ER/donepezil) in
the U.S. Adamas' commercial strategy is to advance its CNS programs through
development and US launch through a specialty CNS sales force, supported by
strategic channel partners in the US and outside of the US. For more
information about Adamas, please visit www.adamaspharma.com.
SOURCE Adamas Pharmaceuticals, Inc.
Contact: BCC Partners, Karen L Bergman, +1-650-575-1509; or Michelle Corral,
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