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In January 2018, Adamas successfully launched GOCOVRI (amantadine) extended release capsules, a prescription medicine for treating dyskinesia (sudden uncontrolled movements) in Parkinson’s disease patients treated with levodopa therapy, with or without other medicines that increase the effects of dopamine in the brain. GOCOVRI is also the first and only medication that has been clinically proven to treat dyskinesia while also reducing OFF time in Parkinson’s disease.
GOCOVRI is supported by GOCOVRI Onboard®, a program designed to support patient access through one direct line of contact, co-pay assistance and timely fulfillment. Questions about GOCOVRI Onboard can be directed to 1-844-GOCOVRI.
For more information, please go to https://www.gocovri.com/getting-gocovri.
“My dyskinesia was preventing me from taking a shower or getting dressed by myself. GOCOVRI helped me manage it, now I’m able to do these unassisted and feel more independent.”
– Dave, person with Parkinson’s
IMPORTANT SAFETY INFORMATION
GOCOVRI® is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2
WARNINGS 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.
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.
How to report an adverse event or product complaint:
Phone: 1-833-223-2627 (1-833-2ADAMAS)
Hours: 24 hrs/day, 7 days/week
Namzaric (memantine hydrochloride extended release and donepezil hydrochloride) capsules is marketed in the United States by Allergan under an exclusive license agreement between Adamas and Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan.
Adamas developed an extended release memantine. In November 2012, Adamas granted Allergan an exclusive license, with right to sublicense, to certain intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells Namzaric and Namenda XR.
From 2Q 2020, Adamas receives royalties on net sales of Namzaric in the United States by Allergan, its affiliates, or any of its sublicensees of controlled-release versions of memantine products covered by the terms of the license agreement.