Osmodex® Drug Delivery System

OSMOLEX ER contains amantadine in an immediate-release outer layer and an extended-release core that is delivered using the Osmodex® Drug Delivery System.1*

*The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell.

Key Features of OSMOLEX ER

  • OSMOLEX ER has a unique pharmacokinetic profile that delivers amantadine throughout the day2
  • Amantadine plasma levels are higher during waking hours and lower during the night2
  • OSMOLEX ER is taken once daily, in the morning1

Comparison of OSMOLEX ER to Immediate-Release Amantadine1,2

Comparison of OSMOLEX ER to immediate release Amantadine

A single-center, laboratory-blinded, randomized, 2-treatment, 2-period, 2-sequence, multiple oral dose crossover study was conducted in 24 healthy volunteers to compare 258-mg OSMOLEX ER tablets to 258-mg amantadine oral syrup.

The efficacy of OSMOLEX ER has been established based on bioavailability studies that compared OSMOLEX ER to immediate-release amantadine.2

The pharmacokinetics of OSMOLEX ER across 3 different dosage strengths were shown to be dose proportional.2

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.


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.


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.


REFERENCES: 1.OSMOLEX ER [prescribing information]. Bridgewater, NJ: Vertical Pharmaceuticals, LLC; 2018. 2. Data on File. Osmotica Pharmaceuticals.