EMERYVILLE, Calif., April 12, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced it will make six data presentations at the 70th Annual Meeting of the American Academy of Neurology (AAN) on April 21-27, 2018 in Los Angeles, California. Adamas will present one platform presentation and four poster presentations regarding GOCOVRI™ (amantadine) extended release capsules, 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. In addition, Adamas will present one poster on ADS-4101 (lacosamide) modified release capsules, in development for the treatment of partial onset seizures in epilepsy.
“These data presentations confirm just how critical understanding symptom timing patterns and designing drug delivery profiles are to developing clinically differentiated medicines that provide large and durable effects for people suffering from chronic neurological diseases,” said Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “Of note, new data will be presented at AAN from the development program of GOCOVRI for the treatment of dyskinesia in people with Parkinson’s disease, including the impact of rate-of-rise in amantadine concentrations on tolerability; the pharmacokinetic profile; effects on non-motor symptoms; and the clinically important differences on the Unified Dyskinesia Rating Scale. These important data further add to the robust medical literature available in support of GOCOVRI.”
Details of the presentations are listed below.
GOCOVRI Poster Presentations
Abstract 2987 / Poster 039: “Effects of ADS-5102 on Non-motor Symptoms (NMS) in Parkinson's Disease Patients with Dyskinesia”
Presenter: Shyamal Mehta, M.D., Ph.D. Assistant Professor, Movement Disorders, Mayo Clinic - Arizona
Date and Time: Sunday, April 22, 2018; 4:00 p.m. – 5:30 p.m.
Abstract 1502 / Poster 052: “A Clinically Important Difference (CID) for the Unified Dyskinesia Rating Scale (UDysRS) Total Score Change in Parkinson's Disease (PD) Patients with Dyskinesia”
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
Date and Time: Monday, April 23, 2018; 5:30 p.m. – 7:00 p.m.
Abstract 1476 / Poster 043: “Pharmacokinetics of ADS-5102 (amantadine) Extended Release Capsules Administered Once-Daily at Bedtime for the Treatment of Dyskinesia”
Presenter: Robert Hauser, M.D., MBA,
Professor of Neurology, Director, USF Health Byrd Parkinson’s Disease and Movement Disorders Center Parkinson Foundation Center of Excellence
Date and Time: Monday, April 23, 2018; 5:30 p.m. – 7:00 p.m.
Abstract 1499 / Poster 064: “Extended-release (ER) Formulations of Aminoadamantanes as NMDA-receptor Antagonists: Pharmacokinetic (PK) Determinants of Improved Tolerability”
Presenter: Jack Nguyen, Ph.D., Vice President, Research, Adamas Pharmaceuticals, Inc.
Date and Time: Thursday, April 26, 2018; 5:30 p.m. – 7:00 p.m.
GOCOVRI Platform Presentation
Abstract 1476 / Platform 006: “Pharmacokinetic/Pharmacodynamic Analysis of Amantadine for Levodopa-Induced Dyskinesia: Correlation of Therapeutic Plasma Concentrations from Multiple Species with Humans”
Presenter: Jack Nguyen, Ph.D., Vice President, Research, Adamas Pharmaceuticals, Inc.
Platform Session Number: S45 - Movement Disorders: Parkinsonian Disorders, Basic Science, and Imaging
Date and Time: Thursday, April 26, 2018; 4:30 p.m.
ADS-4101 Poster Presentation
Abstract 3563 /Poster 263: “Pharmacokinetic Evaluations of ADS-4101 (Lacosamide) Modified Release Capsules Versus Lacosamide IR in Two Phase 1 Studies up to 600 mg”
Presenter: Rajiv Patni, M.D., Chief Medical Officer, Adamas Pharmaceuticals, Inc.
Date and Time: Sunday, April 22, 2018; 4:00 p.m. – 5:30 p.m.
About GOCOVRI
GOCOVRI (amantadine) extended release capsules is the first and only medicine approved by the 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 upon waking and throughout the day. Data from two pivotal, placebo-controlled clinical studies in approximately 200 patients demonstrated statistically significant reduction in dyskinesia, as well as a secondary benefit in OFF time in patients dosed with GOCOVRI. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For more information about GOCOVRI, including complete safety information, please see the U.S. Prescribing Information at www.gocovri.com.
About ADS-4101
ADS-4101 is an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. Derived from Adamas’ validated time-dependent biology approach to drug development, ADS-4101 is a potential high-dose, once-daily at bedtime lacosamide therapy, with a drug profile that provides high concentrations of lacosamide during the day to match the time when seizures occur most often. Lacosamide is an anti-epilepsy active ingredient previously approved by the FDA and currently marketed as VIMPAT® (lacosamide).
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 focused on 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 receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and delivering on its pipeline of differentiated investigational programs, Those programs include: 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 about Adamas’ ongoing or planned clinical development programs 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, 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 22, 2018, particularly under the caption “Risk Factors.” 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.