EMERYVILLE, Calif., Oct. 27, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, the company’s proprietary lead product candidate, for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). In April 2015, the FDA granted orphan drug status to ADS-5102 for this indication.
“The ADS-5102 NDA submission represents a major milestone both for Adamas and for patients with Parkinson’s disease who are challenged to complete the tasks of everyday life as a result of LID,” said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “If approved, ADS-5102 would represent a new approach to treating LID and would be the first drug approved in the United States for this condition. We thank the physicians, patients and caregivers involved in our clinical trials for their pioneering spirit and support in helping us reach this critical milestone.”
The ADS-5102 NDA is supported by efficacy and safety data compiled from Adamas’ comprehensive registration program, which was designed to evaluate ADS-5102 for the treatment of LID in patients with PD. The clinical program included three placebo-controlled trials: EASED, EASE LID and EASE LID 3. The three trials enrolled a total of 286 patients, of whom 121 patients received a 340 mg dose of ADS-5102 once daily at bedtime. Both Phase 3 trials met their primary and key secondary endpoints.
In addition, the NDA is supported by data from an open-label safety study known as EASE LID 2 for patients from EASED, EASE LID and EASE LID 3 as well as LID patients who have undergone deep brain stimulation. The EASE LID 2 trial is ongoing, and patients are being followed for up to two years.
About ADS-5102
ADS-5102 is a chrono-synchronous amantadine therapy for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). ADS-5102 is dosed once daily at bedtime to time the delivery of drug levels of amantadine to waking hours when LID episodes are most frequent and movement control is needed most. With bedtime dosing, the amantadine plasma concentrations rise slowly during the night to avoid sleep disturbance, with peak and plateau achieved from early morning to mid-day, declining in the late afternoon and evening. We are also investigating ADS-5102 for the treatment of walking impairment in multiple sclerosis (MS) patients, and we plan to pursue a pivotal registration program for this indication.
Parkinson's Disease and Levodopa-induced Dyskinesia
Parkinson’s disease (PD) is a chronic neurodegenerative disorder affecting close to 1 million people in the United States. PD 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 PD and is considered the “gold standard.” As a result of PD progression and chronic levodopa therapy, nearly all PD patients will experience levodopa-induced dyskinesia (LID) depending on their levodopa dose. LID is characterized by involuntary movements that are non-rhythmic, purposeless and unpredictable. For additional information, see www.adamaspharma.com
About Adamas Pharmaceuticals, Inc.
Adamas is a pharmaceutical company that is developing new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis and epilepsy. Adamas has pioneered a platform based on an understanding of time-dependent biologic effects of disease activity and drug response to potentially achieve symptomatic relief without additional tolerability issues. We have developed a portfolio of Chrono-synchronous therapies (CSTs) to address neurologic conditions. In addition to ADS-5102, we are investigating ADS-4101 for the improved control of epileptic seizures. Additionally through our license agreement to Allergan, we are eligible to receive royalties on sales of NAMENDA XR® and NAMZARIC® beginning in June of 2018 and May of 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 treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, a potential registration program for ADS-5102 for treatment of walking impairment in MS, additional indications for ADS-5102, and additional products such as ADS-4101. Words such as "look forward," "on track," "expect," "potential," 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 our research, clinical and development activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and our business in general, see our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2016. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We undertake no obligation to update any forward-looking statement in this press release.