The vice president of Medical Affairs at Adamas Pharmaceuticals discussed the context of these results and what the clinical community should take away from the data from the EASE LID 2 trial of amantadine (Gocovri).
Jean Hubble, MD, vice president, Medical Affairs, Adamas Pharmaceuticals
Jean Hubble, MD
A recent announcement from Adamas Pharmaceuticals confirmed that its long-term, open-label EASE LID 2 trial of amantadine (Gocovri) extended-release capsules was successful in the treatment of levodopa-induced dyskinesia in patients with Parkinson disease. The data suggested that treatment with amantadine was safe, tolerable, and resulted in a durable reduction in the motor complications.1,2
The trial included 223 patients, with those in the treatment group reporting lower Movement Disorder Society‐Unified Parkinson’s Disease Rating Scale (MDS‐UPDRS) Part IV scores at baseline—a mean of 6.5 points, compared to 9.4 for the placebo group and 10.5 for the deep brain stimulation (DBS) group—that remained low over the course of the trial.
To find out more about the context of these results and what the clinical community should take away from the data, NeurologyLive spoke to Jean Hubble, MD, vice president, Medical Affairs, Adamas Pharmaceuticals.
Jean Hubble, MD: This 2-year long study demonstrates that Parkinson’s disease patients with levodopa-induced dyskinesia (LID) may derive sustained benefits from GOCOVRI with reduced LID and OFF time resulting in more, good on time. These effects were seen in individuals directly entering this open-label study from earlier controlled trials as well as in patients with suboptimal response to DBS and those switching from amantadine immediate release (IR) to GOCOVRI.
These latter groups, and the fact that physicians could adjust a patient’s other medications as needed, may be more reflective of “real world” clinical experience. Importantly, no new or unexpected adverse drug reactions were detected.
GOCOVRI is the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease. It is also the only medication clinically proven to reduce both dyskinesia and off time. Traditional dyskinesia treatment by lowering levodopa may increase off time, whereas GOCOVRI has been shown to reduce both dyskinesia and off time—pivotal studies showed that it may provide patients with up to four more hours of good on time a day.
GOCOVRI is easy for patients to use—taken once daily at bedtime. Its distinctive formulation delivers therapeutic blood levels in the morning upon awakening that are sustained through most of the waking day which may provide more uninterrupted good ON time for the patient with LID.
We continue to work with the US Parkinson disease community to provide the clinical evidence for the optimal safe and effective use of GOCOVRI in Parkinson disease, as illustrated by the EASE LID 2 study publication. To increase patient access, we are also proud to share that we now offer a 4-week free trial program for new and interested patients.
Transcript edited for clarity.
1. Adamas Announces Publication of the Two-Year Phase 3 Open-Label EASE LID 2 Trial of GOCOVRI® for Dyskinesia in Patients with Parkinson’s Disease. [press release]. Emeryville, CA: Adamas Pharmaceuticals; Published February 11, 2020. globenewswire.com/news-release/2020/02/11/1983417/0/en/Adamas-Announces-Publication-of-the-Two-Year-Phase-3-Open-Label-EASE-LID-2-Trial-of-GOCOVRI-for-Dyskinesia-in-Patients-with-Parkinson-s-Disease.html. Accessed February 11, 2020.
2. Tanner CM, Pahwa R, Hauser RA, et al. EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson’s Disease. J Parkinson Dis. Published online January 6, 2020. doi: 10.3233/JPD-191841.