Adamas announces issuance of new U.S. patent for GOCOVRI in Parkinson’s disease - expands coverage with reduction of ‘OFF’ time and increased ‘good ON’ time
EMERYVILLE, Calif., May 13, 2020 (GLOBE NEWSWIRE) -- 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 it has been issued a new patent (no. 10,646,456) by the United States Patent and Trademark Office (USPTO) that covers GOCOVRI® (amantadine) extended release capsules. The new patent covers a method of reducing ‘OFF’ time and increasing ‘good ON’ time (ON time without troublesome dyskinesia) in people with Parkinson’s disease (PD) being treated with levodopa. GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Data from two pivotal, placebo-controlled phase 3 clinical studies showed that GOCOVRI reduced dyskinesia, as well as a secondary benefit in reduction of OFF time, leading to an increase in good ON time.
This is the second patent to be issued for GOCOVRI that covers reduction in OFF time and will expire in 2034. Adamas’ portfolio of patents for GOCOVRI now includes 15 U.S. patents, across three separate patent families that will expire from 2025 to 2034. This latest addition is listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
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. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.
For more information about GOCOVRI, please visit www.GOCOVRI.com.
About Parkinson’s Disease, Dyskinesia and OFF
Parkinson’s Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients’ lives.
At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.
Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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’ commercial activities relating to GOCOVRI, and 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 7 2020, 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, except as required by law.
Vice President of Corporate Communications
Managing Director, Westwicke