"The full commercial launch of GOCOVRI represents an important milestone for Adamas and will significantly expand awareness of GOCOVRI for both physicians and patients," said
"The launch of GOCOVRI, which was demonstrated in clinical studies to reduce both dyskinesia and OFF time, gives physicians a new tool for the treatment of Parkinson's disease patients with dyskinesia," said Dr.
About Parkinson's Disease and Dyskinesia
GOCOVRI (amantadine) extended release capsules is the first and only medicine approved by the
About GOCOVRI Onboard™
Adamas is committed to helping people with Parkinson's disease and dyskinesia gain access to GOCOVRI. Adamas has created GOCOVRI Onboard, a patient services program, which facilitates access to, and distribution of the medicine. GOCOVRI Onboard will work with patients, their families and physicians to obtain access to GOCOVRI via reimbursement support, prescription fulfillment and financial assistance. GOCOVRI Onboard is designed to deliver dedicated assistance and financial support to patients in need. For more information, visit www.gocovri.com/patient-support/.
About Adamas Pharmaceuticals, Inc.
Adamas uses its deep understanding of time-dependent biology to redefine the treatment experience for patients suffering from chronic neurological diseases. Building upon the commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only
IMPORTANT SAFETY INFORMATION
GOCOVRI™ (amantadine) 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.
Other Anticholinergic Drugs: The dose of GOCOVRI should be reduced if atropine-like effects are observed.
Drugs Affecting Urinary pH: The pH of the urine has been reported to influence the excretion rate of amantadine. Monitor for efficacy or adverse reactions under conditions that alter the urine pH.
Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness, and orthostatic hypotension.
View the full GOCOVRI Prescribing Information.
Statements contained in this press release regarding matters or events 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 expected expanded awareness of GOCOVRI from the commercial launch of GOCOVRI for treatment of levodopa-induced dyskinesia in patients with Parkinson's disease, physician interest in the GOCOVRI, expectations regarding how GOCOVRI Onboard will work, and Adamas' advancing pipeline, including the potential for additional clinical development programs for ADS-5102 including walking impairment in multiple sclerosis, and the advancement of ADS-4101 in clinical development. Words such as "will," "potential," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. 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, ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the
Kim Kraemer415-939-9033 firstname.lastname@example.org Investors: Ashleigh BarretoDirector, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.510-450-3567 email@example.com
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