EMERYVILLE, Calif., April 18, 2017 (GLOBE NEWSWIRE)
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced details regarding upcoming oral platform and poster presentations highlighting pooled data from the Phase 3 EASE LID and EASE LID 3 clinical trials of ADS-5102 (amantadine) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) in people with Parkinson’s disease. The oral platform and poster presentations will be presented at the 69th American Academy of Neurology (AAN) Annual Meeting held in Boston, Massachusetts, April 22-28, 2017.
| Oral Platform Presentation Details | |
| Title: | Pooled Analysis of Phase 3 Studies of ADS-5102 (amantadine) |
| Extended-Release Capsules for Levodopa-Induced Dyskinesia: | |
| A Detailed Review of UDysRS Results | |
| Presenter: | Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of |
| Neurology and Director of the Parkinson's Disease and | |
| Movement Disorder Center at the University of Kansas Medical | |
| Center | |
| Platform Session Number: | S56 |
| Platform Presentation Number: | 003 |
| Platform Presentation Date & Time: | Friday, April 28, 2017, 3:54 p.m. ET |
| Poster Presentation Details | |
| Title: | Pooled Analysis of Phase 3 Studies of ADS-5102 (amantadine) |
| Extended-Release Capsules for Levodopa-Induced Dyskinesia: | |
| A Detailed Review of Parkinson’s Disease Home Diary Results | |
| Presenter: | Caroline Tanner, M.D., Ph.D., Professor of Neurology, |
| University of California San Francisco and San Francisco | |
| Veterans Affairs Medical Center | |
| Poster Presentation Number: | 021 |
| Poster Session Date & Time: | Sunday, April 23, 2017, 8:30 a.m. – 5:30 p.m. ET |
| Author Session Date & Time: | Sunday, April 23, 2017, 4:00 p.m. – 5:30 p.m. ET |
Abstracts can be viewed on the AAN 2017 Annual Meeting website located at https://www.aan.com/conferences/2017-annual-meeting/.
About ADS-5102
ADS-5102 is a high dose amantadine, taken once daily at bedtime, in development for the treatment of levodopa-induced dyskinesia (LID) in people with Parkinson's disease. A New Drug Application (NDA) supporting ADS-5102 for the treatment of LID in people 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 indicated for the treatment of LID in people with Parkinson's disease. Adamas is also investigating ADS-5102 for the treatment of walking impairment in people with multiple sclerosis and is considering developing it for other indications earlier in the Parkinson's disease 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. It 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, which replaces lost dopamine, is the most effective therapy for all stages of Parkinson's disease and is considered the "gold standard" therapy. Over time, patients require increasingly higher or more frequent doses of levodopa in order to avoid the recurrent periods of OFF time when the underlying symptoms of Parkinson’s disease return. As Parkinson’s disease progresses, nearly all patients on levodopa therapy will also experience LID, which is characterized by involuntary movements that are non-rhythmic, purposeless and unpredictable. These patients often experience multiple fluctuating periods of OFF time and LID during any given day, which can impede their movement and daily function. In the United States, approximately 150,000 to 200,000 Parkinson’s patients suffer from LID.
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.
Forward-looking Statements
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, including but not limited to, statements contained in this press release regarding the potential approval of ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease and the presentation of data. Words such as "expect," "anticipate," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' research, clinical, development and commercial activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas' business in general, see Adamas' Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2017. 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:Martin ForrestVice President, Corporate Communications & Investor RelationsAdamas Pharmaceuticals, Inc.Phone: 510-450-3528Email: ir@adamaspharma.com
https://globenewswire.com/news-release/2017/04/18/961798/0/en/Adamas-Announces-Oral-and-Poster-Presentations-of-ADS-5102-Pooled-Phase-3-Data-at-the-69th-American-Academy-of-Neurology-Annual-Meeting.html
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