, June 10, 2014
/PRNewswire/ -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) today presented data on the rater and subject training process utilized in the Phase 2/3 EASED safety and efficacy study of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a condition characterized by involuntary movements without purpose that can become severely disabling, rendering individuals with Parkinson's disease unable to perform routine daily tasks.
In order to achieve consistent study data, standardized rater and subject training was conducted prior to the start of the study. Training was undertaken to ensure uniform understanding of the administration and scoring of each study outcome measure. The training encompassed multiple outcome measures that were utilized during the study.
The Phase 2/3 EASED study met its primary endpoint and the efficacy results of ADS-5102 were aligned across all outcome measures. In addition, ADS-5102 was generally well tolerated with reported adverse events consistent with Parkinson's disease and the known amantadine safety profile.
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, or 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, or TBI.
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 Pharmaceuticals, Inc. 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 or 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, or LID, and as a potential treatment for chronic behavioral symptoms associated with traumatic brain injury, or 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.