About Us | ScientistADMS Adamas Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
GOCOVRI (amantadine)
Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes
|
Approved
Approved
|
FDA Approval announced August 24, 2017. Second approval to include treatment of OFF episodes in PD patients receiving levodopa announced February 1, 2021.
|
|
GOCOVRI (amantadine)
Multiple sclerosis (MS)
|
Phase 3
Phase 3
|
Phase 3 data met primary endpoint at one of two doses. Secondary endpoint in walking impairment not met. Second trial will not be initiated as a result of data - December 17, 2019. Findings were confirmed June 17, 2020.
|
|
Namzaric
Moderate to severe dementia of the Alzheimer's type.
|
Approved
Approved
|
Approved December, 24 2014.
|
Latest News
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Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report second quarter 2021 financial results on Monday, August 9, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.
Investor Conference Call and Webcast
The conference call can be accessed by dialing 1-877-407-9716 for participants in the U.S. or Canada and 1-201-493-6779 for international callers. All callers must provide the following Conference ID: 13720109. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will be available for replay for approximately 30 days.
About Adamas Pharmaceuticals, Inc.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210802005659/en/
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-Drug-product and method-of-use patents strengthen and diversify GOCOVRI's long-term patent portfolio-
-Issuance of ADS-4101 patent in Japan for partial onset seizures in patients with epilepsy strengthens partnering opportunity-
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 announces the issuance of two patents covering GOCOVRI® (amantadine) extended-release capsules: U.S. Patent No. 11,065,213 issued on July 20, 2021, and U.S. Patent No. 11,077,073, projected to issue on August 3, 2021. These two patents are the first issued in this patent family and provide additional claims covering the drug product GOCOVRI, the company's medicine approved as the first and only drug to treat both dyskinesia and OFF motor complications in Parkinson's patients, and methods of using GOCOVRI.
GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy, with or without concomitant dopaminergic medications and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing OFF episodes. Data from two pivotal, placebo-controlled phase 3 clinical studies showed that GOCOVRI reduced dyskinesia in people with Parkinson's, as well as a secondary benefit in reduction of OFF time, leading to an increase in good ON time.
With the issuance of these two patents, Adamas' portfolio of patents for GOCOVRI now includes 17 U.S. patents across four separate patent families that will expire from 2025 to 2038. These latest patents will be listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations, commonly known as the Orange Book. Adamas previously announced settlement agreements with first filers for both available strengths of GOCOVRI, granting non-exclusive licenses from March 4, 2030, or earlier in certain circumstances.
In addition to these two new patents for GOCOVRI, Adamas recently received a new patent covering ADS-4101, its investigational drug candidate being considered for partnering opportunities. This patent, which follows two recently announced U.S. patents for ADS-4101, has been issued in Japan (Japan Patent No. 6902033), and is the first granted in a major market country outside the U.S.
About GOCOVRI
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, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.
Taken once daily at bedtime, GOCOVRI provides an initial lag (delayed release) and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day (extended release). 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 ADS-4101
ADS-4101 is an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. ADS-4101 is a potential high-dose, modified release lacosamide capsule. Lacosamide is an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB SA/NV as VIMPAT® (lacosamide). The development program is currently paused as Adamas evaluates the potential value and options for a path forward for this candidate.
About Adamas
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210722005295/en/
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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 that Neil F. McFarlane, Chief Executive Officer, will participate in a fireside chat at the William Blair Biotech Focus Conference 2021 on Thursday, July 15, 2021 at 1:00 pm Eastern Time.
The fireside chat will be broadcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. Replays of the event will be available for 30 days.
About Adamas Pharmaceuticals, Inc.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210708005682/en/
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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 that the company will present "What's Happening in Parkinson's Disease & the GOCOVRI Opportunity" at the SVB Leerink CNS Forum on Tuesday, June 29th at 1:10 pm Eastern Time.
The presentation will be broadcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. Replays of the event will be available for 30 days.
About Adamas Pharmaceuticals, Inc.
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.
Source: Adamas Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005941/en/
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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® (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.
About Parkinson's disease, OFF and dyskinesia
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 taking levodopa-based therapy are likely to experience reemergence or sudden return of stiffness, rigidity and tremors, referred to as OFF episodes between medication doses, that may be unpredictable. 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 lead to considerable impact on patients' lives.
About GOCOVRI
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, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.
Taken once daily at bedtime, GOCOVRI provides an initial lag (delayed release) and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day (extended release). 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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GOCOVRI is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2WARNINGS AND PRECAUTIONS
Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with Parkinson's disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.
Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression.
Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.
Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.
Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson's disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. Avoid sudden discontinuation of GOCOVRI.
Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.
ADVERSE REACTIONS
The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and, orthostatic hypotension.
Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.
About Adamas
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.
Source: Adamas Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210610005080/en/