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Adamas Announces Final Results from the Two-Year Phase 3 Open-Label Study of GOCOVRI™ in Parkinson's Disease Patients with Dyskinesia

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-- Patients receiving GOCOVRI experienced long-term durability for up to two years --

-- Safety profile was consistent with previously-published controlled Phase 3 studies --

EMERYVILLE, Calif., April 19, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced positive data from EASE LID 2, the company's two-year Phase 3 open-label study of GOCOVRI™ (amantadine) extended release capsules, 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. Overall, results demonstrated that GOCOVRI was generally well tolerated and the treatment effect on motor complications (dyskinesia and OFF), as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part IV, was maintained for up to two years. This effect was seen in all subgroups, including those switched to GOCOVRI from placebo or amantadine immediate release (IR), as well as a subgroup of patients with uncontrollable dyskinesia after deep brain stimulation (DBS) treatment. These data are planned to be presented at the 22nd International Congress of Parkinson's Disease and Movement Disorders (MDS) in Hong Kong, China.

"The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI," said Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, Inc. "The large reduction in dyskinesia and OFF, as assessed by the Part IV score of the MDS-UPDRS, was observed by the first visit at Week 8 and was sustained for two years. This durability is noteworthy given the known progression of motor complications. Nine percent of patients discontinued GOCOVRI due to an adverse drug reaction over this prolonged treatment period and the safety as well as tolerability remained consistent with that obtained from the 64-week data cut from December 2016. Lastly, by two years, 30 percent of patients increased their levodopa dose by an average of approximately 300 mg, suggesting that GOCOVRI treatment may allow neurologists to further optimize their patient's levodopa dose despite the occurrence of dyskinesia."

"When coupled with the Phase 3 controlled studies, this completed open-label study provides supportive evidence that GOCOVRI was able to provide a treatment effect for up to 100 weeks, without waning of benefit in the majority of patients," stated Robert Hauser, M.D., MBA, Professor of Neurology, Director, USF Health Byrd Parkinson's Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence. "These data suggest that further research is warranted to assess whether GOCOVRI could potentially delay the onset or reduce the progression of motor complications."

This final analysis extends and confirms the previously reported results from the 64-week interim analysis published in the Journal of Parkinson's Disease in 2017. At Week 100, the change from baseline in the MDS-UPDRS, Part IV, score was a decrease of -2.4, -3.5, -3.6 units, in patients previously treated with placebo, amantadine IR and DBS, respectively. In contrast, the change from baseline in the previously treated GOCOVRI patients was 0.4 units, demonstrating little change in patients who were already receiving GOCOVRI prior to entry in this open-label study.

The safety data are consistent with the previously reported safety profile of GOCOVRI, which includes precautions and warnings related to suicidality, hallucinations, dizziness and orthostatic hypotension. During the two-year study, nine percent of patients discontinued due to adverse drug reactions (ADRs). Most adverse drug reactions were of mild to moderate intensity, and the most common adverse drug reactions (≥5%) were falls, hallucination, peripheral edema, constipation, urinary tract infection, dizziness, nausea, insomnia, livedo reticularis, dry mouth, depression, anxiety and abnormal dreams. Nine patients died during the course of the study because of cardiac arrest, pneumonia, sepsis, or natural causes; none were deemed study drug related.

About the EASE LID 2 Open-label Safety Study
The EASE LID 2 study is a two-year Phase 3 open-label study of GOCOVRI in 223 Parkinson's disease patients with dyskinesia on levodopa-based therapy. The study enrolled patients from the three GOCOVRI placebo-controlled dyskinesia efficacy trials (EASED, EASE LID and EASE LID 3), as well as Parkinson's disease patients with dyskinesia who have undergone deep brain stimulation (DBS) treatment. The primary objective of the study was 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 MDS-UPDRS, Part IV, as well as evaluating the clinical progression of Parkinson's disease, as assessed by the MDS-UPDRS, Parts I, II, and III.

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. GOCOVRI is a high-dose 274 mg amantadine (340 mg amantadine hydrochloride) taken once-daily at bedtime, which delivers 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 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 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. 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 and ADS-5102, 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.

Contact:

Media: 
Terri Clevenger
Continuum Health Communications
203-227-0209 
tclevenger@continuumhealthcom.com

Investors: 
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com

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