EMERYVILLE, Calif., May 29, 2014 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) today announced a poster presentation at the 18th International Congress of Parkinson's Disease and Movement Disorders from June 8 to 12, 2014, in Stockholm, Sweden. The poster (abstract #722) is titled "Rater training and data completeness in the study of ADS-5102 in levodopa-induced dyskinesia (EASED study)." The poster presentation will take place during the poster session "Parkinson's Disease: Clinical Trials" on Tuesday, June 10, 2014, from 12:30pm to 2:30pm CET in Stockholm.
The EASED study investigated the safety and efficacy of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a dose-limiting adverse event of levodopa as prescribed for Parkinson's disease. As previously disclosed, the trial met its primary endpoint, with once daily doses at bedtime generally well tolerated and resulting in significant dose-dependent improvements in LID. Additional data from the study will be presented at the 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 patients with Parkinson's disease with troublesome LID were randomized to placebo or ADS-5102, dosed once daily at bedtime 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 included change from baseline in: the 24-hour patient diary, the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Clinician's Global Impression of Change (CGIC).
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, a condition characterized by involuntary movements without purpose. LID can become severely disabling, rendering patients unable to perform routine daily tasks. As Parkinson's disease advances, 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.
Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), a high dose, controlled-release version of amantadine, that is administered once daily at bedtime. Adamas is initially developing ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. LID is a movement disorder that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for Parkinson's disease. There are no approved drugs for the treatment of LID in the United States or Europe. Adamas is also evaluating ADS-5102 as a potential treatment for chronic behavioral symptoms associated with traumatic brain injury (TBI).
Adamas is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company achieves this by modifying 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 (LID), and as a potential treatment for chronic behavioral symptoms associated with traumatic brain injury (TBI). The company's portfolio also includes a fixed-dose combination product candidate, MDX-8704, being developed with Forest Laboratories, Inc. and an approved controlled-release product Namenda XR®, which Forest developed and is marketing in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
SOURCE Adamas Pharmaceuticals, Inc.