EMERYVILLE, Calif., April 23, 2014 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a specialty pharmaceutical company, today announced a poster presentation at the American Academy of Neurology (AAN) 66th Annual Meeting, April 26 to May 3, 2014, in Philadelphia, PA.
The poster (4009), is titled, "Safety and Efficacy Study of ADS-5102 (amantadine HCl) extended release capsules in Levodopa-Induced Dyskinesia (EASED Study)." The poster presentation will take place during Poster Session IV on Wednesday, April 30, 2014, from 7:30 to 11:00 a.m. The EASED study investigated the safety and efficacy of different doses of ADS-5102 extended release capsules for the treatment of levodopa-induced dyskinesia (LID), a dose-limiting adverse effect of Parkinson's disease treatment. As previously disclosed, the trial met its primary endpoint, with once nightly doses generally well tolerated and resulting in significant dose-dependent improvements in LID. Additional data from the study will be presented at the AAN meeting.
EASED Trial Design The Phase 2/3 EASED trial was a randomized, double-blind, placebo-controlled, parallel-group study conducted at sites throughout the United States. Eighty-three Parkinson's disease patients with troublesome LID were randomized to placebo or one of three doses of ADS-5102 (260 mg, 340 mg and 420 mg), dosed once nightly for eight weeks. The primary outcome measure was the change from baseline to week eight in the Unified Dyskinesia Rating Scale (UDysRS) total score. Secondary outcome measures were: change from baseline in 24-hour patient diaries, the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Clinician's Global Impression of Change (CGI-C). The trial met it primary endpoint, with once nightly doses generally well tolerated and resulting in significant dose-dependent improvements in LID.
Parkinson's Disease and Levodopa-induced Dyskinesia (LID) Parkinson's disease is a chronic, progressive motor disorder that causes tremors, rigidity, slowed movements and postural instability. The Parkinson's Disease Foundation estimates that there were approximately one million people living with Parkinson's disease in the United States in 2011.
The most commonly prescribed treatments for Parkinson's disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. Patients initially receive relief from symptoms of Parkinson's disease for much of the day; this period of relief is known as "ON" time. As the effects of levodopa wear off, the symptoms of Parkinson's disease return; this is known as "OFF" time. By properly managing the timing of levodopa administration, patients with early-stage Parkinson's disease can largely avoid "OFF" time during the day.
Over time, as Parkinson's disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Even with increased doses of levodopa, patients may begin to exhibit unpredictable "OFF" episodes throughout the day. In the later stages of the disease, many patients will suffer from LID. LID can become severely disabling, rendering patients unable to perform routine daily tasks. As Parkinson's disease progresses, the symptoms of LID worsen in frequency and severity. Eventually the total time that a patient spends either "OFF" or "ON" with troublesome LID can become a majority of his or her day.
About Adamas Pharmaceuticals, Inc. Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. Adamas achieves this by enhancing the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing its lead wholly owned product candidate, ADS-5102, for a complication of Parkinson's disease known as levodopa-induced dyskinesia and as a treatment for chronic behavioral symptoms associated with traumatic brain injury.