EMERYVILLE, Calif., Feb. 9, 2015 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that results from its Phase 2/3 clinical study of ADS-5102 (EASED) have been published in the online issue of the peer-reviewed journal Movement Disorders. ADS-5102 is initially being developed by Adamas for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. ADS-5102, an investigational agent, is a long-acting, extended-release capsule formulation of amantadine HCl administered once daily at bedtime.
The randomized double-blind, placebo-controlled, parallel group study evaluated 83 patients with troublesome LID. Patients were assigned to receive placebo or one of three dose levels of ADS-5102. Results from the study demonstrate that ADS-5102 significantly reduced dyskinesia, as measured by change in the Unified Dyskinesia Rating Scale (UDysRS) total score over eight weeks versus placebo at the 340 mg (p=0.005) dose level. In addition, ADS-5102 significantly increased ON time without troublesome dyskinesia by 3 hours per day, as assessed by Parkinson's disease patient diaries change from baseline relative to placebo at the 340 mg (p=0.008) dose level. ADS-5102 was generally well tolerated; the most common adverse events were constipation, hallucinations, dizziness, and dry mouth.
"The Phase 2/3 EASED study suggests that ADS-5102 administered at bedtime improved dyskinesia in Parkinson's disease patients," said principal investigator Rajesh Pahwa, MD, University of Kansas Medical Center, Kansas City, and lead author on the study. "Over 40 percent of patients receiving levodopa to control their Parkinson's disease symptoms develop motor fluctuations and dyskinesia within five years of treatment that can negatively impact their quality of life. There is a clear need for a medical treatment for dyskinesia that can be debilitating in some patients, and ADS-5102 is a promising therapy."
Comprehensive Phase 3 Clinical Program
Adamas is currently conducting three clinical trials for the treatment of LID in individuals with Parkinson's disease, including:
- EASE LID, a Phase 3 trial enrolling approximately 130 patients. The 26-week multi-center, randomized, double-blind, placebo-controlled trial will assess the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime. The primary endpoint of EASE LID is a reduction in dyskinesia assessed by changes in UDysRS.
- EASE LID 3, a Phase 3 study enrolling approximately 70 patients. The 13-week multi-center, randomized, double-blind, placebo-controlled study will assess the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime.
- EASE LID 2, a Phase 3 open-label safety study of ADS-5102 in Parkinson's disease patients with LID.
Parkinson's Disease and Levodopa-induced Dyskinesia (LID)
Parkinson's disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability. 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.
As Parkinson's disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Patients may also experience symptoms of their disease upon waking, prior to the first dose of levodopa taking effect. Over time 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 LID can become a majority of his or her day.
About Adamas Pharmaceuticals
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 associated with the treatment of Parkinson's disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company's portfolio also includes two approved products developed with Forest Laboratories Holdings Limited, a subsidiary of Actavis plc. The first is a fixed-dose combination product, Namzaric™,and the second is an extended-release product, Namenda XR®. Forest markets both products 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.
Namzaric™ is a trademark of Actavis, Inc. or its affiliates.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "May," "will," "expect," "anticipate," "estimate," "intend," "would," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Such statements contained in this press release include expectations regarding the potential of ADS-5102. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to clinical and development activities of ADS-5102 and its safety and efficacy profile, as well as risks relating to Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2014. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.
CONTACT: For questions, please contact: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528
Source:Adamas Pharmaceuticals, Inc.