Adamas Announces Final Results from the Two-Year Phase 3 Open-Label Study of GOCOVRI™ in Parkinson’s Disease Patients with Dyskinesia
-- Patients receiving GOCOVRI experienced long-term durability for up to two years --
-- Safety profile was consistent with previously-published controlled Phase 3 studies --
“The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI,” said
“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
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.
GOCOVRI (amantadine) extended release capsules is the first and only
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
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
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Source: Adamas Pharmaceuticals, Inc.