Adamas Announces Publication of Data Supporting the Benefits of GOCOVRI™ in Parkinson’s Disease Patients with Dyskinesia
“The results from this pooled analysis of two Phase 3 studies confirms the consistency of GOCOVRI’s benefit on dyskinesia and OFF time, as demonstrated in the individual studies across different Parkinson’s disease patient populations and all primary and secondary endpoint measures,” said lead author
The pooled analysis included the UDysRS, the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) patient-reported Parkinson’s disease home diary data, and Clinician’s Global Impression of Change (CGI-C) data collected in both Phase 3 studies. In addition to the reported 41 percent reductions in dyskinesia in the UDysRS, reductions in both dyskinesia and OFF were seen in the diary data, as well as a nearly 4-hour improvement in ON time without troublesome dyskinesia. In addition, 52 percent of patients in the GOCOVRI-treated group reported a complete resolution of their ON time with troublesome dyskinesia by Week 12, compared with 23 percent of patients in the placebo-treated group. Moreover, 25 percent of patients in the GOCOVRI-treated group reported a complete resolution of their OFF time, compared with 14 percent of patients in the placebo group.
“With its demonstrated, consistent clinical efficacy, GOCOVRI finally provides a solution for physicians and patients needing a proven durable treatment for dyskinesia in people with Parkinson’s disease,” said
In the pooled Phase 3 analysis, most adverse reactions were of mild to moderate intensity, and the most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.
GOCOVRI (amantadine) extended release capsules is the first and only medicine approved by the
About Adamas Pharmaceuticals, Inc.
Adamas is using its deep understanding of time-dependent biology to redefine the treatment experience for patients suffering from chronic neurological diseases. The company is building upon the commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only
For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.
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
1 Pooled Analyses of Phase 3 Studies of ADS-5102 (Amantadine) Extended Release Capsules for Dyskinesia in Parkinson's Disease, CNS Drugs http://bit.ly/2pbdV9U
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Source: Adamas Pharmaceuticals, Inc.