Adamas Pharmaceuticals Initiates Phase 3 Trial For ADS-5102 In Parkinson's Disease Patients With Levodopa-Induced Dyskinesia
EMERYVILLE, Calif., June 9, 2014 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) announced today that it has initiated a pivotal Phase 3 clinical study of ADS-5102 (amantadine HCl), a high-dose, controlled-release version of amantadine for the treatment of patients with Parkinson's disease who have developed levodopa-induced dyskinesia (LID). LID is 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.
The Phase 3 study (EASE LID) will enroll approximately 130 patients. It is a 26-week multi-center, randomized, double-blind, placebo-controlled trial, which will assess the efficacy of a once daily 340 mg dose of ADS-5102 administered at bedtime for the treatment of LID in individuals with Parkinson's disease. The primary endpoint of EASE LID is a reduction in LID as assessed by changes in the Unified Dyskinesia Rating Scale (UDysRS) along with supporting data from secondary endpoints.
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.
This press release contains "forward-looking" statements, including, without limitation, statements related to the process and timing of anticipated future clinical development of Adamas' product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "planned," "will," "may," "expect," and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Adamas' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the availability of resources to develop Adamas' product candidates, Adamas' need for additional capital in the future to sufficiently fund its operations and research, the uncertain timing of completion of and the success of clinical trials, market competition, as well as other risks detailed from time to time in Adamas' reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. Adamas does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
SOURCE Adamas Pharmaceuticals, Inc.