Adamas Presents New Data Analysis Demonstrating that GOCOVRI™ Reduces Transitions between Dyskinesia and OFF Episodes Throughout the Day
EMERYVILLE, Calif., June 22, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the presentation of new data analysis of GOCOVRI™ (amantadine) extended release capsules, from the Phase 3 pivotal studies, demonstrating that the reductions in both dyskinesia and OFF experienced by GOCOVRI-treated patients results in longer periods of ON time without troublesome dyskinesia and reduced transitions between Parkinson’s disease diary states. The analysis will be presented in an oral poster, entitled ADS-5102 Reduces ON Time with Troublesome Dyskinesia and OFF Time Throughout the Waking Day-Time Course Analysis,at the 2nd Annual Pan American Parkinson’s Diseases and Movement Disorders Congress in Miami, FL.
GOCOVRI is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in people with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the first FDA-approved drug to improve dyskinesia as well as demonstrate a secondary benefit in reducing OFF, in these patients.
“The Parkinson’s disease home diary data from the GOCOVRI Phase 3 pivotal studies clearly show that the entire waking day may be impacted by troublesome dyskinesia. Of note, troublesome dyskinesia can happen in the morning after a patient takes the first dose of levodopa,” said Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “By Week 12, GOCOVRI-treated patients experienced a decrease in the number of transitions between these diary states, resulting in longer periods of uninterrupted ON time without troublesome dyskinesia. The observation that 17 percent of GOCOVRI-treated patients did not experience any transitions during the waking day is particularly noteworthy. This new analysis provides a useful definition of transitions that reinforces the previously reported data of GOCOVRI on dyskinesia and OFF.”
During the study, 162 patients (77 treated with GOCOVRI and 85 with placebo) provided a complete and evaluable Parkinson’s disease home diary at both baseline and Week 12. At Week 12, the reductions in both dyskinesia and OFF for GOCOVRI-treated patients resulted in much longer periods of ON time without troublesome dyskinesia. GOCOVRI-treated patients, on average, experienced a 3.2-hour placebo adjusted increase in their first episode of ON time without troublesome dyskinesia. In addition, at Week 12, GOCOVRI-treated patients experienced 4.2 less transitions between diary states a day compared to 2.0 less transitions for placebo-treated patients. Approximately 17 percent of GOCOVRI-treated patients become transition-free versus approximately one percent of placebo-treated patients. The safety data was consistent with the overall population of the pivotal trials for GOCOVRI. The most common adverse reactions (>10 percent) were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.
About Parkinson’s Disease and Dyskinesia
In the United States, there are close to one million people living with Parkinson’s disease, a chronic neurodegenerative disorder, and an estimated 150,0000 – 200,000 people recognizing they have dyskinesia. Parkinson’s disease is characterized by dopamine deficiency combined with an over-activated glutamate system, which contributes to the symptoms of dyskinesia and OFF, which is characterized by slowness of movement, rigidity, impaired walking, tremor, and postural instability. Over time, nearly 90 percent of people with Parkinson’s disease develop dyskinesia, which occurs throughout the day. Dyskinesia is a consequence of levodopa-based treatment and progression of Parkinson’s disease, and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which often impacts the activities of daily living. Until approval of GOCOVRI, the primary strategy to manage dyskinesia has been to fractionate or lower the levodopa dose, which may reduce dyskinesia in some cases, but because of the reduced levodopa dosing, can lead to increased OFF in patients.
GOCOVRI (amantadine) extended release capsules is the first and only FDA-approved medicine indicated 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 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 reducing OFF in patients dosed with GOCOVRI. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For more information about GOCOVRI, including complete safety information, please see the U.S. Prescribing Information at www.gocovri.com.
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 FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and delivering on its pipeline of differentiated investigational programs. Those programs include: 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. 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 3, 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.
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