"GOCOVRI's approval is an important advancement for the treatment of Parkinson's disease, as it is the first
GOCOVRI is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs. Dyskinesia is a consequence of levodopa-based Parkinson's disease treatment and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which impact the activities of daily living.
"Dyskinesia can significantly compromise quality of life for people with Parkinson's disease," said Dr.
GOCOVRI's positive benefit/safety profile was established in two Phase 3 controlled clinical trials in Parkinson's disease patients with dyskinesia. In Study 1, patients treated with GOCOVRI demonstrated statistically significant and clinically relevant reductions in dyskinesia, with a 37 percent reduction in Unified Dyskinesia Rating Scale (UDysRS) total score vs. 12 percent for placebo at Week 12. These results were confirmed in Study 2 in which GOCOVRI achieved a 46 percent reduction in UDysRS vs. 16 percent for placebo. Additionally, key secondary data from Parkinson's disease patient reported diaries in Study 1 and Study 2 respectively, showed that GOCOVRI-treated patients experienced a 3.6 and 4.0 hour increase in functional time daily (defined as ON time without troublesome dyskinesia) vs. a 0.8 and 2.1 hour increase for placebo-treated patients at Week 12. The increases in functional time were achieved by decreases in both ON time with troublesome dyskinesia and OFF time. The placebo-adjusted reduction in OFF time in both studies was approximately 1 hour per day. The most commonly observed adverse reactions ( > 10 percent and greater than placebo) with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For additional Important Safety Information, see below.
"Today's approval is a tremendous milestone for Adamas and for the Parkinson's disease community," said
GOCOVRI is expected to be available in the fourth quarter, and formally launched with the full deployment of Adamas's sales force in
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About Parkinson's Disease and Dyskinesia
Parkinson's disease is a chronic neurodegenerative disorder affecting close to one million people in the
Over time, nearly 90 percent of people on levodopa therapy experience dyskinesia, which is characterized by involuntary and non-rhythmic movements during waking hours that are purposeless and unpredictable. Dyskinesia can interfere with people's daily living, resulting in functional impairment and disability. People with Parkinson's disease often experience multiple fluctuating periods of OFF time and dyskinesia during any given day, which can impede their movement and daily function. In the
GOCOVRI is the first and only medicine approved by the
At Adamas, we believe in the power and the promise of medicines derived from a deep understanding of time-dependent biology. Our expertise lies in uncovering and mapping the relationship between disease and drug activity. From there, we strive to create medicines with therapeutic profiles that match the pattern of disease to drive a more significant and durable clinical effect. This understanding of time-dependent biological processes informs our every innovation, targeting advancement in treatment of chronic neurologic disorders. Our portfolio includes: GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only
NAMENDA XR® and NAMZARIC® are trademarks of
IMPORTANT SAFETY INFORMATION
GOCOVRI TM 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.
Statements contained in this press release regarding expected future events 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 benefits of GOCOVRI, physician and patient access in fourth quarter 2017 and launch of GOCOVRI (amantadine) extended release capsules (previously ADS-5102) in
Ashleigh BarretoDirector, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.510-450-3567 email@example.com Media Kelley KaufmaninVentiv Health 805-637-2491 Kelley.Kaufman@inventivhealth.com
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