Adamas Presents Final Results from the Two-Year, Phase 3 Open-Label Study of GOCOVRI™ in Parkinson’s Disease Patients with Dyskinesia

Oct 8, 2018
  • GOCOVRI was generally well tolerated and the safety profile was consistent with previously reported data for up to two years
  • Results show a comparable 35% reduction from baseline in dyskinesia and OFF was achieved across all subgroups naïve to GOCOVRI as measured by MDS-UPDRS, Part IV
  • Over 84% of GOCOVRI-treated patients maintained or increased levodopa dosage for up to 100 weeks
  • Data presented at 22nd International Congress of Parkinson’s Disease and Movement Disorders

EMERYVILLE, Calif., Oct. 08, 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 the presentation of final results from EASE LID 2, the company’s two-year Phase 3 open-label study of GOCOVRI™ (amantadine) extended release capsules, 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. These data were presented in two posters at the 22nd International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Hong Kong, China.

Overall, final results from the two-year, open-label study demonstrated that GOCOVRI was generally well tolerated. The data also showed the treatment effect of GOCOVRI on motor complications (dyskinesia and OFF), as measured by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV, was maintained for up to two years. This effect was seen in all subgroups, including those switched to GOCOVRI from placebo (N=78) or amantadine immediate release (IR) (N=32) and those with uncontrollable dyskinesia after deep brain stimulation (N=61) treatment, and was achieved without compromising the underlying control of Parkinson’s disease symptoms, as assessed by MDS-UPDRS, Parts I-III, which measures the non-motor and motor signs of Parkinson’s disease.

“These open label study results demonstrate how the GOCOVRI Phase 3 controlled clinical data can translate into real-world benefits,” said Dr. Caroline Tanner, MD, PhD, Professor at University of California San Francisco. “There is now up to two years of clinical evidence that further supports the overall safety profile and efficacy of GOCOVRI is consistent with previously reported data from the two pivotal Phase 3 studies. We have reassurance that with GOCOVRI treatment, physicians and patients can see sustained reductions in dyskinesia and OFF over time.”

In the study, GOCOVRI provided a comparable 35 percent reduction in dyskinesia and OFF from baseline by Week 8 (first post-baseline visit) that was maintained for up to 100 weeks across all subgroups naïve to GOCOVRI, including those switched directly from amantadine IR. In addition, over 84 percent of GOCOVRI-treated patients either increased or had no change to their levodopa dosage for up to 100 weeks with 30 percent increasing their doses by an average of approximately 300 mgs/day.

“We are pleased to present the final data set from our two-year open-label study with GOCOVRI, which demonstrates the clinical benefits of GOCOVRI in people with Parkinson’s disease dyskinesia,” said Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “Notably in the final safety and tolerability analysis, we saw that adverse events over this two-year period were consistent with the previous Phase 3 trials and that most discontinuations were unrelated to the drug. In fact, the comprehensive GOCOVRI clinical trial dataset on sustained reductions in dyskinesia and OFF provides physicians with the evidence needed to prescribe GOCOVRI for their patients.”

The safety data are consistent with the previously reported safety profile of GOCOVRI, which includes precautions and warnings related to suicidality, hallucinations, dizziness and orthostatic hypotension. Discontinuations were mostly due to reasons not related to an adverse drug reaction (ADR). During the two-year study, nine percent of patients discontinued due to adverse drug reactions compared to 33 percent who discontinued for reasons other than ADR. Most adverse drug reactions were of mild to moderate intensity, and the most common adverse drug reactions (>10%) were falls, hallucination, peripheral edema, constipation and urinary tract infection. Nine patients died during the course of the study because of cardiac arrest, pneumonia, sepsis, or natural causes; none were deemed study drug related.

About the EASE LID 2 Open-label Study
The EASE LID 2 study was a two-year Phase 3 open-label safety study of GOCOVRI in 223 Parkinson’s disease patients with dyskinesia on levodopa-based therapy. The study enrolled patients from the three GOCOVRI placebo-controlled dyskinesia efficacy trials (EASED, EASE LID and EASE LID 3), as well as Parkinson’s disease patients with dyskinesia who have undergone deep brain stimulation (DBS) treatment. The primary objective of the study was to characterize the long-term safety and tolerability of GOCOVRI dosed at bedtime for the treatment of dyskinesia in patients with Parkinson’s disease. Secondary objectives included evaluating the durability of GOCOVRI on motor complications (dyskinesia and OFF) as assessed by the MDS-UPDRS, Part IV, as well as evaluating the clinical progression of Parkinson’s disease, as assessed by the MDS-UPDRS, Parts I, II, and III.

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 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 prior to the first dose of levodopa and throughout the day, and lower levels at night. 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.

Contacts:

Media:
Terri Clevenger
Continuum Health Communications
203-856-4326
tclevenger@continuumhealthcom.com

Investors:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com

 

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Source: Adamas Pharmaceuticals, Inc.