ADMS Adamas Pharmaceuticals Inc

Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, today announced that posters regarding GOCOVRITM (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and ADS-5102 (amantadine) extended release capsules for walking impairment in patients with multiple sclerosis (MS) will be presented at the 71st Annual American Academy of Neurology (AAN) Meeting being held May 4-10, 2019 in Philadelphia. 

"New data from our two-year open label study suggest chronic GOCOVRI treatment may enable the dose of dopaminergic medications to be modified with an improvement in OFF and dyskinesia. We hope these data, coupled with the GOCOVRI pivotal program, can provide confidence to neurologists to increase the use of dopaminergic therapies alongside adjunctive GOCOVRI to benefit their PD patients," said Rajiv Patni, MD, Chief Medical Officer of Adamas. "In addition, we're looking forward to discussing the baseline demographics and study design features of INROADS, our ongoing Phase 3 study to assess the potential efficacy and safety of ADS-5102 for walking impairment in patients with MS."

Details of the poster presentations are below:

GOCOVRI Poster PresentationTitle: Changes to Levodopa Daily Dose in Parkinson’s Disease (PD) Patients with Dyskinesia While on GOCOVRITM (amantadine) Extended Release Capsules: A Two-Year Phase 3 Open Label Study AnalysisPresenter: Dr. Stuart Isaacson, Parkinson's Disease & Movement Disorders Center of Boca RatonPoster ID:  P4.7-010Poster Session 4: Movement Disorders ePoster SessionDate and Time: Thursday, May 9, 2019; 11:30 a.m. – 6:30 p.m. ET ADS-5102 Poster PresentationTitle: INROADS: A Phase 3 Study to Assess the Efficacy and Safety of ADS-5102 (amantadine) Extended Release Capsules in Multiple Sclerosis Patients with Walking ImpairmentPresenter: Dr. Michelle Cameron, Oregon Health and Science University Poster ID: P5.2-087Poster Session 5: MS Symptom Assessment and ManagementDate and Time: Wednesday, May 9, 2019; 11:30 a.m. – 6:30 p.m. ET

About GOCOVRI QHS GOCOVRITM (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 (QHS), 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 common side effects of GOCOVRI include dry mouth, swelling of legs and feet, constipation, and falls. 

For more information about GOCOVRI, please see the U.S. Prescribing Information at www.GOCOVRI.com.

About ADS-5102 Adamas is currently evaluating ADS-5102 in a Phase 3 clinical program for walking impairment in patients with multiple sclerosis. ADS-5102 was previously approved by the FDA under the trade name GOCOVRI™ (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is not FDA-approved for the treatment of walking impairment in patients with multiple sclerosis.

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.

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

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