EMERYVILLE, Calif., March 28, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced details regarding a poster presentation highlighting data from EASE LID, its Phase 3 efficacy study of ADS-5102 (amantadine hydrochloride) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease, to be presented at the Academy of Managed Care Pharmacy’s (AMCP) 2017 Annual Meeting held in Denver, Colorado, March 27 – 30, 2017. The poster will be available for review at an author session on March 28, from 5:45p.m. – 7:30p.m. MDT, and for general review on March 29, from 11:45a.m. – 2:45p.m. MDT.
Poster Presentation Details
| Title: | ADS-5102 (amantadine hydrochloride) Extended-Release Capsules Improve Clinician’s Global Impression of Change (CGI-C) and Activities of Daily Living (ADL) by Reducing Levodopa-Induced Dyskinesia (LID) in Parkinson’s Disease (EASE LID Study) |
| Abstract and Poster Number: | G10 |
| Author Hour Poster Session Date: | Tuesday, March 28 |
| Author Hour Poster Session Time: | 5:45p.m. – 7:30p.m. MDT |
| Poster Session Date: | Wednesday, March 29 |
| Poster Session Time: | 11:45a.m. – 2:45p.m. MDT |
| Room: | Colorado Convention Center Hall DE |
About the EASE LID Study
The Phase 3 EASE LID study was a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of 340 mg of ADS-5102 dosed once daily at bedtime for 24 weeks in patients with LID associated with Parkinson’s disease. The study's primary efficacy analysis measured the reduction in LID over 12 weeks as assessed by the Unified Dyskinesia Rating Scale (UDysRS). The key secondary efficacy outcome measures were a reduction in LID over 24 weeks as assessed by the UDysRS and changes in a standardized Parkinson’s Disease home diary, including ON time without troublesome dyskinesia and OFF time at weeks 12 and 24. Additional secondary efficacy outcome measures included overall Parkinson’s Disease clinical status as assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Clinician's Global Impression of Change (CGI-C).
About ADS-5102
ADS-5102 is a chrono-synchronous amantadine therapy with potential applications across several chronic neurologic disorders. Adamas is focusing initial development on the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. A New Drug Application (NDA) supporting ADS-5102 for the treatment of LID in patients with Parkinson’s disease is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017. If approved, ADS-5102 will be the first and only FDA-approved medicine for the treatment of LID in patients with Parkinson’s disease. Adamas is also investigating ADS-5102 for the treatment of walking impairment in multiple sclerosis patients and is considering developing it for other indications in Parkinson’s disease earlier in the treatment journey.
About Parkinson's Disease and Levodopa-induced Dyskinesia
Parkinson's disease is a chronic neurodegenerative disorder affecting close to 1 million people in the United States. Parkinson's disease is characterized by the progressive loss of dopaminergic neurons, causing lower levels of endogenous dopamine and manifesting as symptoms of bradykinesia (slowness of movement), rigidity, impaired walking, tremor and postural instability. Levodopa is the most effective therapy for all stages of Parkinson's disease and is considered the "gold standard" therapy. As a result of the disease progression and chronic levodopa therapy, nearly all Parkinson's disease patients will experience LID depending on their levodopa dose. LID is characterized by involuntary movements that are non-rhythmic, purposeless and unpredictable.
About Adamas Pharmaceuticals, Inc.
Adamas develops new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Parkinson’s disease, multiple sclerosis, epilepsy and Alzheimer’s disease. Adamas has pioneered a platform to develop medicines, called chrono-synchronous therapies, for chronic neurologic disorders based on an understanding of the time-dependent biologic processes responsible for disease activity and drug response to potentially achieve symptomatic relief without tolerability issues. The company’s most advanced product candidate, ADS-5102, is in development for levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease and walking impairment. An NDA supporting ADS-5102 for the treatment of LID in patients with Parkinson’s disease is under review by the FDA, with a PDUFA date of August 24, 2017. Adamas is exploring other indications for ADS-5102 for further development. Adamas is also investigating ADS-4101 for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas’ licensed assets, NAMENDA XR® and NAMZARIC®, are currently marketed by Allergan, and Adamas is eligible to receive royalties on sales of these medicines beginning in June 2018 and May 2020, respectively. For more information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz Pharma GmbH & Co. KGaA.