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Adamas Pharmaceuticals Presents New Traumatic Brain Injury Data From Its Nurelin™ Program at American Academy of Neurology Conference


3/20/2013 9:21:41 AM

EMERYVILLE, Calif., March 20, 2013 /PRNewswire/-- Adamas Pharmaceuticals, Inc. will present research results today from its NurelinTM (amantadine HCl extended release capsules) program demonstrating the benefit of amantadine in traumatic brain injury (TBI) at the 65th 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 treatment.

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 at www.easedPD.com.

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.


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