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GOCOVRI

In January 2018, Adamas successfully launched GOCOVRI® (amantadine) extended release capsules, a prescription medicine for treating dyskinesia (sudden uncontrolled movements) in Parkinson’s disease patients treated with levodopa therapy, with or without other medicines that increase the effects of dopamine in the brain. In February 2021, Adamas received FDA approval for a second indication for GOCOVRI as a treatment for Parkinson’s disease patients receiving levodopa/carbidopa and experiencing OFF episodes (including stiffness, rigidity, and tremors occurring in between medication doses). GOCOVRI is the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinson’s disease.

GOCOVRI is supported by GOCOVRI Onboard®, a program designed to support patient access through one direct line of contact, co-pay assistance and timely fulfillment. Questions about GOCOVRI Onboard can be directed to 1-844-GOCOVRI.

For more information, please go to https://www.gocovri.com/getting-gocovri.

Thriving with Parkinson's

“My dyskinesia was preventing me from taking a shower or getting dressed by myself. GOCOVRI helped me manage it, now I’m able to do these unassisted and feel more independent.”

– Dave, person with Parkinson’s

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GOCOVRI is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2


WARNINGS AND PRECAUTIONS
Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with Parkinson’s disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.
Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression.
Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.
Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.
Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. Avoid sudden discontinuation of GOCOVRI.
Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.


ADVERSE REACTIONS
The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.

Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.

 

How to report an adverse event or product complaint:

Phone: 1-833-223-2627 (1-833-2ADAMAS)
Hours: 24 hrs/day, 7 days/week
Fax: 866-681-1063

OSMOLEX ER

On January 4, 2021, Adamas acquired the global rights to OSMOLEX ER® (amantadine) extended release tablets from Osmotica Pharmaceuticals US LLC, a subsidiary of Osmotica Pharmaceuticals plc. In February 2018, the FDA-approved OSMOLEX ER for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.

AccessOsmolex is a patient support center that is focused on helping with OSMOLEX ER access and coverage at an affordable price. For questions regarding OSMOLEX ER prescriptions and refills, call the AccessOsmolex Support Center at 1-833-OSMOLEX (1-833-676-6539).

INDICATION
OSMOLEX® ER (amantadine) extended-release tablets is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.


IMPORTANT SAFETY INFORMATION
CONTRAINDICATION:
OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2).

WARNINGS AND PRECAUTIONS:
Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with amantadine have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. Before initiating treatment with OSMOLEX ER, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk of somnolence with OSMOLEX ER, such as concomitant sedating medications, alcohol, or the presence of a sleep disorder. If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (eg, driving a motor vehicle, conversations, eating), OSMOLEX ER should ordinarily be discontinued. If a decision is made to continue OSMOLEX ER, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if they become somnolent.
Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.
Suicidality and Depression: Suicide, suicide attempts, and suicidal ideation have been reported in patients with and without prior history of psychiatric illness while treated with amantadine. Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits of treatment with OSMOLEX ER outweigh the risks in patients with a history of suicidality or depression.
Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with OSMOLEX ER due to the risk of exacerbating psychosis. Monitor patients for hallucinations throughout treatment but especially after initiation and after the dose of OSMOLEX ER is increased or decreased.
Dizziness and Orthostatic Hypotension: Patients should be monitored for these adverse reactions, especially after starting OSMOLEX ER or increasing the dose.
Withdrawal-Emergent Hyperpyrexia and Confusion: Abrupt discontinuation of OSMOLEX ER may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. It is recommended that patients avoid sudden discontinuation of OSMOLEX ER.
Impulse Control/Compulsive Behaviors: Patients can experience increased sexual urges, and intense urges to gamble, spend money, binge eat, and/or other intense urges, and the inability to control these urges while taking one or more medications that increase central dopaminergic tone, including OSMOLEX ER. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges while being treated with OSMOLEX ER. Consider dose reduction or stopping the medication if a patient develops such urges while taking OSMOLEX ER.


ADVERSE REACTIONS
The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

DRUG INTERACTIONS:
Other Anticholinergic Drugs: The dose of anticholinergic drugs or of OSMOLEX ER should be reduced if atropine-like effects appear when these drugs are used concurrently.
Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.
Drugs Affecting Urinary pH:The pH of urine has been reported to influence the excretion rate of amantadine. Alterations in urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse reactions. Monitor for efficacy or adverse reactions under conditions that alter the urine pH to more acidic or alkaline, respectively.
Live Attenuated Influenza Vaccines: Amantadine may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live vaccines are not recommended during treatment with OSMOLEX ER. Inactivated influenza vaccines may be used as appropriate.
Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for central nervous system effects such as somnolence, dizziness, confusion, lightheadedness, and orthostatic hypotension.

How to report an adverse event or product complaint:

Phone: 1-877-482-3788
Visit the FDA: http://www.fda.gov/medwatch
Call the FDA: 1-800-FDA-1088

Namzaric

Namzaric® (memantine hydrochloride extended release and donepezil hydrochloride) capsules is marketed in the United States by Allergan under an exclusive license agreement between Adamas and Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan.

Adamas developed an extended release memantine. In November 2012, Adamas granted Allergan an exclusive license, with right to sublicense, to certain intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells Namzaric and Namenda XR.

From 2Q 2020, Adamas receives royalties on net sales of Namzaric in the United States by Allergan, its affiliates, or any of its sublicensees of controlled-release versions of memantine products covered by the terms of the license agreement.

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