Adamas Pharmaceuticals Presents Update On NurelinTM Program At Cambridge Healthtech Institute’s Parkinson’s Conference
EMERYVILLE, CALIF., June 4, 2012 - Adamas Pharmaceuticals, Inc., a privately held company, announced today that it will present an update on its NurelinTM (amantadine HCl extended release capsules) program at the Cambridge Healthtech Institute’s (CHI) Targeting Parkinson’s Disease Symposium being held today in Philadelphia. Nurelin, a once-daily extended release formulation of amantadine intended for night-time administration, is being developed for the treatment of levodopa- induced dyskinesia (LID) in Parkinson’s disease (PD) patients. Results from the Company’s prior Phase 1 studies, its preclinical program in Parkinson’s and other indications, along with a status report on the ongoing Phase 3 study, Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASEDTM), will be presented by Gregory T. Went, Ph.D., Co-Founder and Chief Executive Officer of Adamas. The talk is entitled, “Exploring the Potential of Modified Release Aminoadamantanes in Parkinson’s Disease and Related Indications.”
"We are excited to introduce the Nurelin program at the conference today, and to provide an update on the previous preclinical and clinical studies that have led to our first Phase 2/3 study of Nurelin in Parkinson’s patients who experience levodopa-induced dyskinesia,” said Dr. Went. “Amantadine is a remarkable drug that has received little attention from the pharmaceutical industry for the past 30 years, and we hope the EASED study of Nurelin, combined with recently presented academic studies in Parkinson’s disease, will help establish new treatment indications for Nurelin. We look forward to presenting the results from this study and assessing the potential of Nurelin as our second NDA candidate to ArimendaTM."
There are no medications currently approved for the treatment of levodopa-induced dyskinesia, thus there is a significant unmet medical need. Pending the outcome of the EASED study and regulatory review, Nurelin may become the first drug indicated for the treatment of levodopa-induced dyskinesia in Parkinson’s disease. Nurelin also is being investigated as a therapeutic agent to address the non-motor symptoms of Parkinson’s disease, including fatigue.
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 capsules can be opened and the contents sprinkled on food for ease of administration in patients who have difficulty swallowing capsules.
Nurelin has a pharmacokinetic profile designed to overcome 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 the tolerability of the new formulation (www.easedPD.com).
About LID in Parkinson Disease
Parkinson's disease is a chronic, progressive disorder with prominent motor signs including tremors, rigidity, bradykinesia and postural instability. Levodopa, the most commonly prescribed and effective drug treatment for symptomatic relief in PD is associated with dose limiting motor side effects, including abnormal involuntary, dance-like movements known as dyskinesia. With continued levodopa treatment, and as PD progresses, dyskinesia can become severely disabling and has been associated with a decrease in the quality of life.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, based in Emeryville, California with operations in Bangalore, India, is the leading developer of aminoadamantane-based therapeutics for CNS disorders. The company’s research and development platform is focused on developing controlled release versions and optimized fixed dose combinations of aminoadamantanes to address major dosing and titration challenges that limit the use of currently available therapeutics. Adamas is advancing two programs from this platform through Phase 3 clinical studies, including Nurelin (amantadine HCl extended release capsules), initially for levodopa-induced dyskinesia in patients with Parkinson’s disease and Arimenda (memantine HCl extended release and donepezil HCl) capsules for Alzheimer’s disease. Both products are designed to improve tolerability and clinical efficacy, and to provide superior clinical and health economic benefits. For more information about Adamas, please visit www.adamaspharma.com.