Adamas Announces Publication of Data Demonstrating Dyskinesia’s Impact on Activities of Daily Living in People with Parkinson’s Disease
GOCOVRI is the first and only medicine approved by the
“Dyskinesia in people with Parkinson’s disease is a levodopa dose-limiting consequence of disease progression and chronic levodopa therapy, which can impair ADLs across multiple tasks,” said
According to the Unified Dyskinesia Rating Scale (UDysRS) Part 1B, a component of the Patient Questionnaire that covers ten questions on the impact of dyskinesia on ADLs, GOCOVRI-treated patients experienced a statistically significant improvement on six of the 10 ADLs: walking and balance (P < 0.0001), eating tasks (P = 0.0052), doing hobbies and other activities (P = 0.0159), public and social settings (P = 0.0165), exciting or emotional settings (P = 0.0310), and speech (P = 0.0494), compared to placebo-treated patients at Week 12. The difference between GOCOVRI and placebo was statistically significant in all seven body regions, most markedly in the arms/shoulders (P ≤ 0.0001), and for three of the four ADL tasks at Week 12: ambulation (P = 0.0007), dressing (P = 0.0074), and drinking (P = 0.0112), as assessed by the UDysRS Part 3 and Part 4, respectively.
“This analysis of the two GOCOVRI Phase 3 studies shows that treatment with GOCOVRI can ameliorate the impairment that dyskinesias can cause on ADLs across multiple tasks. While dyskinesia often limits the ability to use levodopa to its fullest, leaving people with Parkinson’s disease at risk of more OFF time, these data also demonstrate that dyskinesia impacts their daily lives,” said
In the pooled Phase 3 analysis, most adverse reactions were of mild to moderate intensity, and the most common (>10%) adverse reactions were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.
These data will be presented in a poster at the 22nd International
About Parkinson’s Disease and Dyskinesia
GOCOVRI (amantadine) extended release capsules is 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.
Patients should take their medicine at bedtime as instructed. GOCOVRI may be taken with or without food.
For additional important safety information, please see GOCOVRI full 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 commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only
Statements contained in this press release regarding matters 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 potential clinical benefits of GOCOVRI or about Adamas’ ongoing or planned clinical development programs 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 and ADS-5102, the regulatory and competitive environment and Adamas' business in general, see Adamas’ Annual Report on Form 10-Q filed with the
1. Pahwa, R. “Impact of dyskinesia on activities of daily living in Parkinson's disease: Results from pooled Phase 3 ADS-5102 clinical trials”, Parkinsonism and Related Disorders https://bit.ly/2yfA62i
Terri Clevenger Continuum Health Communications203-227-0209 email@example.com Investors: Ashleigh BarretoDirector, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.510-450-3567 firstname.lastname@example.org
Source: Adamas Pharmaceuticals, Inc.