EMERYVILLE, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that pooled Phase 3 data of GOCOVRI™ (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, were published online in CNS Drugs1. Results from the two pooled Phase 3 studies in Parkinson’s disease patients with dyskinesia demonstrated that GOCOVRI-treated patients experienced a 41 percent reduction in dyskinesia from baseline at Week 12, compared to 14 percent in placebo-treated patients, as assessed by the Unified Dyskinesia Rating (UDysRS) total score.
“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 Lawrence W. Elmer, MD, PhD, University of Toledo.
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 Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “Patients take GOCOVRI once-daily at bedtime, which provides them with high amantadine concentrations upon waking and throughout the day when dyskinesia and OFF occur, and then lower concentrations in the evening when amantadine can disrupt sleep patterns. What’s most important from this pooled analysis, is that over half of patients treated with GOCOVRI reported a complete resolution of their ON time with troublesome dyskinesia at 12 weeks.”
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.
About GOCOVRI
GOCOVRI (amantadine) extended release capsules is the first and only medicine approved by the FDA 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 consistently 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. For more information about GOCOVRI, please see the important safety information below and the U.S. Prescribing Information at www.gocovri.com.
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 FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease, with a pipeline of differentiated investigational programs, which includes: 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. Adamas’ goal is to create and commercialize a new generation of neurological medicines intended to lessen the burden of disease on patients, caregivers and society.
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.
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