Adamas Announces New Safety and Efficacy Data for GOCOVRI® in Parkinson’s Disease Patients with Dyskinesia at the Movement Disorder Society 2019 International Congress

/EIN News/ -- EMERYVILLE, Calif., Sept. 20, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, announced today the presentation of new data on GOCOVRI^® (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy at the Movement Disorder Society (MDS) 2019 International Congress, September 22-26, 2019 in Nice, France. The poster presentations will highlight data derived from the GOCOVRI development program and post-marketing pharmacovigilance surveillance.

“Adamas’ purpose is to significantly improve the lives of people affected by neurological diseases, and we remain committed to the presentation of GOCOVRI data to provide further information to support robust clinical discussions,” said Rajiv Patni, MD, Chief Medical Officer at Adamas. “Our goal is to ensure that neurologists understand how GOCOVRI may be an option for their Parkinson’s disease patients with dyskinesia on dopaminergic therapies by providing them with a treatment that may increase functional ON time by decreasing both dyskinesia and OFF.”

The five posters will be part of the “Clinical Trials, Pharmacology and Treatment” session on Monday, September 23, 2019, from 1:45-3:15pm Central European Time (CET). Details of the poster presentations are as follows:

	Poster 106: “The Effect of GOCOVRI on Motor Aspects of Experiences of Daily Living: Analyses of MDS-UPDRS Part II Data from a Phase 3 Program” Lead Author: Dr. Robert Hauser, University of South Florida
	Poster 107: “Analysis of the Shape of the GOCOVRI Steady-state PK Profile: Implications for an Extended Release Product” Lead Author: Dr. Robert Hauser, University of South Florida
	Poster 115: “GOCOVRI Dose Adjustment in Elderly Parkinson’s Patients at Risk for Renal Impairment: Implications from an Exposure Simulation Model” Lead Author: Dr. Stuart Isaacson, Parkinson's Disease & Movement Disorders Center of Boca Raton
	Poster 171: “The Efficacy and Safety of GOCOVRI Based on Age: Special Population Analyses of a Phase 3 Study Program” Lead Author: Dr. Rajesh Pahwa, University of Kansas Medical Center
	Poster 213: “Safety of GOCOVRI in Clinical Practice: One-Year Post-Launch Pharmacovigilance Data” Lead Author: Dr. Caroline Tanner, University of California, San Francisco

About Parkinson’s Disease, OFF and Dyskinesia

Parkinson’s Disease (PD) is a progressive, neurodegenerative disorder caused by a dysregulation of neurotransmitter signaling, afflicting approximately one million people in the United States. The gradual loss of brain cells producing the neurotransmitter dopamine leads to this dysregulation, which results in motor (movement related) and non-motor symptoms. The primary PD treatment approach is with levodopa, a dopamine precursor, that works by entering the brain and being converted to dopamine. While this replacement of dopamine is initially highly effective in relieving motor symptoms, over time, many patients develop a fluctuating, and unpredictable response to levodopa. At low dopamine levels, patients experience stiffness and rigidity, referred to as “OFF” periods, while at high dopamine levels they experience involuntary movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of OFF, dyskinesia and normal movement lead to considerable disruption of patients’ lives. At this stage of the disease since the motor symptoms and underlying glutamate hyperactivity are thought to follow a diurnal pattern across the waking day of patients, a therapy that effectively attenuates glutamate hyperactivity using a time-dependent approach, may help improve good motor control throughout the waking day in individuals with dyskinesia and OFF.

About GOCOVRI
GOCOVRI^® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine proven to reduce both dyskinesia and OFF.

GOCOVRI is thought to work by reducing the amount of glutamate hyperactivity in a region of the brain that controls movement, in patients experiencing dyskinesia and OFF. The NMDA receptor is activated by glutamate and causes post-synaptic nerve signaling in this area of the brain, which is modulated by dopamine.  Levodopa therapy replaces dopamine lost in Parkinson’s disease but may result in large fluctuations in synaptic levels of dopamine during waking hours, further exacerbating glutamate hyperactivity. GOCOVRI, developed by Adamas, is novel in that it selectively blocks the NMDA receptor in a time-dependent manner.  Taken at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night and a high concentration from the morning and throughout the waking day. Additionally, the adjunctive use of GOCOVRI does not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. For more information about GOCOVRI, please see the U.S. Prescribing Information at www.GOCOVRI.com.

About Adamas Pharmaceuticals, Inc.
Adamas’ goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI™ (amantadine) extended release capsules, 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. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.

Important Safety Information

Before taking GOCOVRI, patients should tell their doctor about all medical conditions, including if they:

• have kidney problems; unexpected sleepiness; take medicine to help them sleep or that makes them drowsy; have mental problems, such as suicidal thoughts, depression, or hallucinations; unusual urges including gambling, increased sex drive, compulsive eating, or shopping; or if they drink alcoholic beverages.

• are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. GOCOVRI may harm the unborn baby and can pass into breastmilk.

Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, especially if medicines like sodium bicarbonate are taken.

What should patients avoid while taking GOCOVRI? Patients should NOT:

• Take GOCOVRI if they have severe kidney problems.
• Drive, operate machinery, or do other dangerous activities until they know how GOCOVRI affects them.
• Drink alcohol while taking GOCOVRI as it can increase their chances of serious side effects.
• Stop or change the dose of GOCOVRI before talking with their doctor.
• Take a flu nasal spray vaccine while taking GOCOVRI, but they can receive a flu shot.

What are the possible side effects of GOCOVRI?

GOCOVRI may cause serious side effects, including:

• falling asleep during normal activities, such as driving, talking, or eating, while taking GOCOVRI. Patients may fall asleep without being drowsy or warning. 

• suicidal thoughts or actions and depression.

• occurrence or worsening of hallucinations (seeing or hearing things that are not real).

• feeling dizzy, faint or light headed, especially when standing up too quickly, when first starting GOCOVRI, or if a patient’s dose has been increased.

• unusual urges including gambling, sexual, spending money, binge eating, and the inability to control them.

If a patient or their family notices that they are developing any new, unusual or sudden changes in behavior or related symptoms, inform the patient’s healthcare provider right away.

The most common side effects of GOCOVRI include dry mouth, swelling of legs and feet, constipation, and falls.

For additional important safety information, please see GOCOVRI full Prescribing Information at www.gocovri.com.

Contacts:

Investors:
Peter Vozzo
Westwicke Partners
443-213-0505
Peter.vozzo@westwicke.com  

Media: 
Sarah Mathieson
Vice President, Communications and Engagement
Adamas Pharmaceuticals, Inc.
510-450-3528
smathieson@adamaspharma.com