EMERYVILLE, Calif., Oct. 04, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, today announced that pooled Phase 3 data of GOCOVRI™ (amantadine) extended release capsules were published online in Parkinsonism and Related Disorders1. The paper entitled, Impact of dyskinesia on activities of daily living in Parkinson's disease: Results from pooled Phase 3 ADS-5102 clinical trials, concluded that dyskinesias in people with Parkinson’s disease can impact a patient's activities of daily living (ADLs) across multiple tasks, and that treatment with GOCOVRI can help ameliorate the impairment.
GOCOVRI is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only drug approved by the FDA to treat dyskinesia in people with Parkinson’s disease on levodopa therapy, as well as demonstrate a secondary benefit in reducing OFF time in that population.
“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 Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology and Director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas Medical Center. “The management of Parkinson’s disease primarily focuses on the patient’s OFF time, and because the impact of dyskinesia on ADLs has not been extensively studied it may be underappreciated by patients and their physicians. Further studies integrating quality of life measures should be undertaken to more fully characterize the impairment and integrate these findings into Parkinson’s disease management plans.”
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 Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, Inc. “Patients take GOCOVRI at bedtime, which provides them with high amantadine concentrations upon waking, before their first dose of levodopa, and throughout the day when dyskinesia and OFF typically impacts ADLs.”
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 Congress of Parkinson’s Disease and Movement Disorders (MDS) being held in Hong Kong, China, October 5-9, 2018.
About Parkinson’s Disease and Dyskinesia
In the United States, there are close to one million people living with Parkinson’s disease, a chronic neurodegenerative disorder, and an estimated 150,0000 – 200,000 people recognizing they have dyskinesia. Parkinson’s disease is characterized by dopamine deficiency combined with an over-activated glutamate system, which contributes to the symptoms of dyskinesia and OFF, which is characterized by slowness of movement, rigidity, impaired walking, tremor, and postural instability. Over time, nearly 90 percent of people with Parkinson’s disease develop dyskinesia, which occurs throughout the day. Dyskinesia is a consequence of levodopa-based treatment and progression of Parkinson’s disease, and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which often impacts the activities of daily living. Until approval of GOCOVRI, the primary strategy to manage dyskinesia has been to fractionate or lower the levodopa dose, which may reduce dyskinesia in some cases, but because of the reduced levodopa dosing, can lead to increased OFF in people with Parkinson’s disease.
About GOCOVRI
GOCOVRI (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is a high-dose 274 mg amantadine (340 mg amantadine hydrochloride) taken once at bedtime, which delivers high levels of amantadine upon waking and throughout the day. Data from two, placebo-controlled Phase 3 clinical studies in approximately 200 patients demonstrated statistically significant reduction in dyskinesia, as well as a secondary benefit in OFF time in patients dosed with GOCOVRI. For more information about GOCOVRI, including complete safety information, please see the U.S. Prescribing Information at www.gocovri.com.
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 FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and delivering on its pipeline of differentiated investigational programs. Those programs include: ADS-5102 in development for the treatment of multiple sclerosis walking impairment; and ADS-4101, a high-dose, modified release lacosamide in development for the treatment of partial onset seizures in patients with epilepsy. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.
Forward-looking Statements
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 Securities and Exchange Commission on August 2, 2018, particularly under the caption “Risk Factors.” Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.
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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