Adamas Announces Publication of Pharmacokinetic Data for GOCOVRI™ in Clinical Pharmacokinetics

May 24, 2018

EMERYVILLE, Calif., May 24, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that pharmacokinetic (PK) data regarding GOCOVRI™ (amantadine) extended release capsules were published online in Clinical Pharmacokinetics. The paper, entitled Pharmacokinetics of ADS-5102 (Amantadine) Extended Release Capsules Administered Once-Daily at Bedtime for the Treatment of Dyskinesia concluded that GOCOVRI demonstrated a slow initial rise in amantadine plasma concentration and can be dosed effectively once-daily at bedtime to achieve high amantadine plasma concentrations upon waking and during the day. 

GOCOVRI is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in people with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the first FDA-approved drug to improve dyskinesia in these patients, as well as demonstrate a secondary benefit in OFF.

“Dyskinesia in Parkinson’s disease patients typically occurs in the morning and throughout the waking day when patients take their levodopa. This is when they need the most help in managing their symptoms, including dyskinesia and OFF,” said Robert A. Hauser MD, MBA, Professor of Neurology and Director, USF Health Byrd Parkinson’s Disease and Movement Disorders Center Parkinson Foundation Center of Excellence. “The PK data reported in this paper show that GOCOVRI has a significantly different profile than amantadine immediate release, allowing for a bedtime dose resulting in a slow rise to the high plasma concentration upon waking prior to taking dopaminergic treatments.”

The publication reported on three studies to evaluate the single-dose and steady-state PK of GOCOVRI in healthy volunteers, directly comparing with corresponding PK values for amantadine immediate release (IR), along with the steady-state PK in patients with Parkinson’s disease. When administered at bedtime, GOCOVRI’s profile results in high amantadine plasma concentrations upon waking and throughout the day, with lower amantadine plasma concentrations in the evening. In contrast, amantadine IR dosed two to three times during the day was characterized by low amantadine plasma concentrations upon waking with higher amantadine plasma concentrations in the evening into the night, potentially contributing to sleep related adverse events associated with high doses of amantadine. At the approved recommended dosage of 274 mg given once-daily at bedtime, GOCOVRI provided 3.0- and 2.0-fold higher amantadine plasma concentrations upon waking, compared to amantadine IR given two or three times during the day, respectively.

“This publication provides a clear picture of PK data to date from Adamas’ clinical pharmacology program,” said Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals, Inc. “The data support GOCOVRI’s unique PK profile, which is distinctly different from the PK curves achieved with the commonly prescribed dosing regimens of amantadine immediate release. The PK profile of GOCOVRI achieved with once-daily bedtime dosing results in high amantadine concentrations before the patient has taken their first levodopa dose and has yet to experience the unpredictable episodes of dyskinesia and OFF that invariably occur during waking hours. These studies demonstrate that GOCOVRI is significantly different than amantadine IR and that the two formulations are not bioequivalent either at single dose or at steady-state.”

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 time, 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 time in patients. 

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-daily at bedtime, which delivers high levels of amantadine upon waking and throughout the day. Data from two pivotal, placebo-controlled 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. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For more information about GOCOVRI, including complete safety information, 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 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-K filed with the Securities and Exchange Commission on February 22, 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.

 

Contact:

Media:
Terri ClevengerContinuum Health Communications
203-227-0209
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.