Benzinga | Jun 10, 2021 09:16AM EDT

Adamas Pharma Highlights New Data Analysis Supporting GOCOVRI As Treatment For Motor Complications For People With Parkinson's Disease

Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the publication of a new data analysis titled, "Effects of GOCOVRI(r) (amantadine) extended-release capsules on motor aspects of experiences of daily living in people with Parkinson's disease and dyskinesia" in the peer-reviewed journal of Neurology and Therapy. The publication highlights a post-hoc data analysis from two placebo-controlled Phase 3 clinical trials, including a total of 196 patients. Results from the analysis were driven primarily by improvements in motor activities important to patients such as freezing, tremor, and getting out of bed/car/deep chair.

"For people living with Parkinson's disease, motor complications often have a broad impact on daily activities," said Robert A. Hauser, M.D., M.B.A., Professor of Neurology and Director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida. "The improvements in patient-perceived disability associated with motor aspects of PD -- such as freezing of gait, tremors, and getting out of bed -- support the use of GOCOVRI as an important treatment option for PD motor complications."

"This analysis suggests that GOCOVRI may meaningfully reduce the impact of PD motor symptoms on experiences of daily living," said Adrian Quartel, Chief Medical Officer, Adamas. "The suggestion that GOCOVRI may impact gait freezing is a particularly interesting finding because freezing appears to be separate from the disease's primary motor symptoms and is a noted unmet need in the treatment of Parkinson's."

In two randomized Phase 3 trials (EASE LID and EASE LID 3), GOCOVRI or placebo was administered for at least 12 weeks to a total of 196 people with Parkinson's, and the treatment impact of GOCOVRI on dyskinesia was assessed using the Unified Dyskinesia Rating Scale (UDysRS). In this post-hoc analysis, the treatment impact of GOCOVRI on patient-reported motor experiences of daily living was assessed using Part II of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

At week 12, participants treated with GOCOVRI reported statistically significant improvements in motor control for daily activities compared to placebo (least-squares mean changes from baseline of --3.4 points for GOCOVRI and --1.4 for placebo). The overall treatment difference with GOCOVRI was driven primarily by statistically significant improvements in items related to freezing, tremor, and getting out of bed/car/deep chair. For patients who reported at least mild scores (?2, problematic) for freezing of gait at baseline, 53.8% taking GOCOVRI and 17.1% taking placebo improved to a nonproblematic score of 0 (none) or 1 (slight) at week 12. For those reporting at least a mild score for tremors at baseline, 66.7% taking GOCOVRI and 35.9% taking placebo improved to a nonproblematic score at week 12. Limitations of this exploratory analysis include the post-hoc nature of the component analysis and insufficient presence of disability for several items at baseline that may affect the ability to show response.