The safety and tolerability profile of these patients was consistent with prior controlled studies.
EMERYVILLE, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc.. (Nasdaq:ADMS) today announced that subgroup analyses of Parkinson’s disease patients taking amantadine immediate release (IR) who were still experiencing dyskinesia and enrolled into EASE LID 2, the long-term, ongoing Phase 3 open-label study of GOCOVRI™ (amantadine) extended release capsules, were published online in Movement Disorders Clinical Practice1. Results from the subgroup analysis showed that the 32 Parkinson’s disease patients who were taking amantadine IR at enrollment experienced a 35 percent improvement in motor complications at Week 8, the first post-baseline visit, after transitioning directly to GOCOVRI, without exacerbating adverse events. The effects were maintained for the 64-week period assessed. The safety and tolerability profile of these patients was consistent with prior controlled studies.
“These data suggest that patients currently being treated with amantadine IR could be switched directly to GOCOVRI without interruption,” stated Stuart Isaacson, MD, Director of the Clinical Research Center at the Parkinson’s Disease and Movement Disorders Center of Boca Raton. “The results of this subgroup analysis, while open-label, continue to support the benefits of GOCOVRI in the treatment of Parkinson’s disease patients with dyskinesia and OFF.”
“We continue to collect and analyze data from our EASE LID 2 open-label Phase 3 clinical trial, as we further characterize the benefits and risks of GOCOVRI,” said Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “We look forward to completing the study and reporting topline findings in the second quarter of 2018.”
The analyses were previously presented in a poster session at the XXIII World Congress of Neurology (WCN), September 16–21, 2017, Kyoto, Japan.
About the EASE LID 2 Open-label Study
The EASE LID 2 study is a long-term, ongoing Phase 3 open-label study of GOCOVRI for the treatment of dyskinesia patients with Parkinson’s disease. The study enrolled 223 patients from the three GOCOVRI placebo-controlled efficacy trials in Parkinson’s disease patients with dyskinesia (EASED, EASE LID and EASE LID 3), as well as Parkinson’s disease patients with dyskinesia who have undergone deep brain stimulation (DBS) treatment. Patients are being followed for up to two years. The primary objective of the study is to characterize the long-term safety and tolerability of GOCOVRI dosed once daily at bedtime for the treatment of dyskinesia in patients with Parkinson’s disease. Secondary objectives include evaluating the durability of GOCOVRI on motor complications (dyskinesia and OFF) as assessed by the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV, as well as evaluating the clinical progression of Parkinson’s disease.
About GOCOVRI
GOCOVRI (amantadine) extended release capsules is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is a high-dose 274 mg amantadine (340 mg amantadine hydrochloride) taken once daily at bedtime, which delivers consistently high levels of amantadine in the morning and throughout the day. Data from two pivotal, placebo-controlled clinical studies in over 200 patients demonstrated statistically significant reduction in dyskinesia, as well as a secondary benefit in reducing OFF in patients dosed with GOCOVRI. For more information about GOCOVRI, please see the important safety information and the U.S. Prescribing Information at www.gocovri.com.
About Adamas Pharmaceuticals, Inc.
Adamas is using its deep understanding of time-dependent biology to redefine the treatment experience for patients suffering from chronic neurological diseases. The company is building upon the commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease, with a pipeline of differentiated investigational programs, which includes ADS-5102 in development for the treatment of multiple sclerosis walking impairment; and ADS-4101, a high-dose, modified-release lacosamide in development for the treatment of partial-onset seizures in patients with epilepsy. Adamas’ goal is to create and commercialize a new generation of neurological medicines intended to lessen the burden of disease on patients, caregivers and society. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.
Forward-looking Statements
Statements contained in this press release regarding matters that may occur in the future 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 clinical benefits of GOCOVRI or the completion of the EASE LID 2 and reporting topline findings in the second quarter of 2018 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 GOCOVRI and ADS-5102, the regulatory and competitive environment and Adamas’ business in general, see Adamas’ Current Report on Form 8-K filed with the Securities and Exchange Commission on January 22, 2018. 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.
1 Parkinson’s patients with dyskinesia switched from immediate release amantadine to open-label ADS-5102 Movement Disorders Clinical Practice https://goo.gl/WKqPbA
Contacts: Media: Kim Kraemer 415-939-9033 Investors: Ashleigh Barreto Director, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. 510-450-3567
