Adamas Announces Publication and Presentation of a Data Analysis Demonstrating GOCOVRI Reduces Both the Frequency and Duration of Daily Episodes of Troublesome Dyskinesia and OFF in Parkinson’s Disease
GOCOVRI® is the first and only medicine approved by the
“We often don’t realize the prevalence and unpredictability of these transitions from episodes of troublesome dyskinesia and OFF, and how they can disrupt a patient’s day and quality of life,” said
Participants in the GOCOVRI® pivotal Phase 3 trials filled out diaries documenting their motor state every 30 minutes over the course of a day, both at baseline and week 12 of the study. These data were used to map the daily patterns of dyskinesia and OFF episodes and evaluate the ability of GOCOVRI® to reduce the number and duration of these poor motor control states. Based on evaluable diary data from 162 patients, episodes of dyskinesia and OFF occur sporadically throughout the day, with patients experiencing, on average, just over eight transitions between episodes of OFF, Good ON, and troublesome dyskinesias. GOCOVRI® reduced both the number and duration of troublesome dyskinesia and OFF episodes relative to placebo, such that patients experienced approximately half as many transitions between troublesome dyskinesia and OFF at endpoint vs baseline. The duration of the first episode of the day on Good ON time increased by an average of 5.2 hours in the GOCOVRI® group, compared with 2.0 hours for placebo. Good ON time is defined as time spent in the ON state without experiencing troublesome dyskinesia.
“In the retrospective analysis of the diary data from our Phase 3 study, we see that GOCOVRI® significantly reduced both the number and duration of troublesome dyskinesia and OFF episodes relative to placebo, allowing patients to experience fewer and shorter episodes and increasing the duration of continuous Good ON time,” said
About Parkinson’s Disease, OFF and Dyskinesia
Parkinson’s Disease (PD) is a progressive, neurodegenerative disorder caused by a dysregulation of neurotransmitter signaling, afflicting approximately one million people in
About GOCOVRI® QHS
GOCOVRI® (amantadine) extended-release capsules is the first and only
GOCOVRI® is thought to work by reducing the amount of glutamate hyperactivity in a region of the brain that controls movement, in patients experiencing dyskinesia and OFF. The NMDA receptor is activated by glutamate and causes post-synaptic nerve signaling in this area of the brain, which is modulated by dopamine. Levodopa therapy replaces dopamine lost in Parkinson’s disease, but may result in large fluctuations in synaptic levels of dopamine during waking hours, further exacerbating glutamate hyperactivity. GOCOVRI®, developed by
For more information about GOCOVRI®, please see the U.S. Prescribing Information at www.GOCOVRI.com.
About Adamas Pharmaceuticals, Inc.
Adamas’ goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only
Important Safety Information
Before taking GOCOVRI®, patients should tell their doctor about all medical conditions, including if they:
- Have kidney problems; unexpected sleepiness; take medicine to help them sleep or that makes them drowsy; have mental problems, such as suicidal thoughts, depression, or hallucinations; unusual urges including gambling, increased sex drive, compulsive eating, or shopping; or if they drink alcoholic beverages.
- Are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. GOCOVRI® may harm the unborn baby and can pass into breastmilk.
Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, especially if medicines like sodium bicarbonate are taken.
What should patients avoid while taking GOCOVRI®? Patients should NOT:
- Take GOCOVRI® if they have severe kidney problems.
- Drive, operate machinery, or do other dangerous activities until they know how GOCOVRI® affects them.
- Drink alcohol while taking GOCOVRI® as it can increase their chances of serious side effects.
- Stop or change the dose of GOCOVRI® before talking with their doctor.
- Take a flu nasal spray vaccine while taking GOCOVRI®, but they can receive a flu shot.
What are the possible side effects of GOCOVRI?
GOCOVRI may cause serious side effects, including:
- Falling asleep during normal activities, such as driving, talking, or eating, while taking GOCOVRI®. Patients may fall asleep without being drowsy or warning.
- Suicidal thoughts or actions and depression.
- Occurrence or worsening of hallucinations (seeing or hearing things that are not real).
- Feeling dizzy, faint or light headed, especially when standing up too quickly, when first starting GOCOVRI®, or if a patient’s dose has been increased.
- Unusual urges including gambling, sexual, spending money, binge eating, and the inability to control them.
If a patient or their family notices that they are developing any new, unusual or sudden changes in behavior or related symptoms, inform the patient’s healthcare provider right away.
The most common side effects of GOCOVRI® include dry mouth, swelling of legs and feet, constipation, and falls.
For additional important safety information, please see GOCOVRI® full Prescribing Information at www.gocovri.com.
Vice President, Communications & Engagement
Source: Adamas Pharmaceuticals, Inc.