FDA Recently Approved Osmolex ER (Extended Release Amantadine)

The FDA announced approval for a new formulation of amantadine, Osmolex ER, which can be used as a treatment for Parkinson’s disease (PD).

Amantadine is an antiviral medication, which traditionally is used to treat PD and other muscle and nervous conditions as well as flu infections. For both indications, amantadine can be given alone and in combination with other medications.

Amantadine, a generic available by prescription only, has been prescribed to facilitate more normal body movements by increasing muscle control and easing body stiffness. The indications for use include PD, parkinsonisms, and for known side effects of certain medications prescribed for nervous, mental and emotional conditions.1

Osmolex ER

Osmotica, a specialty pharmaceutical company headquartered in Marietta, Georgia with a portfolio and pipeline of Central Nervous System (CNS) drugs to treat multiple sclerosis and Parkinson’s, has received the go-ahead for production of Osmolex ER. The drug combines newly patented osmotic technology, that requires only one morning dose a day to provide both immediate and extended release medication. The new technology combines formulations in order to release controlled dosages of amantadine throughout the day.2

Indications

The FDA has approved Osmolex ER for adults with Parkinson’s as well as drug induced extrapyramidal reactions.3 Parkinson’s is a neurodegenerative motor disorder characterized by tremor, rigidity, and problems with gait. Non-motor symptoms of PD can include changes to vision, speech and mental health. Extrapyramidal reactions are drug-induced physical symptoms that express themselves to resemble those of movement disorders. Attributed to improper dosing or adverse reactions to antipsychotics, they can include tremor, slurred speech, dystonia and bradyphrenia (slowness of thought). There can also be psychological side effects like increased anxiety and paranoia.

Dosing

The tablets come in three doses that can be increased on weekly intervals to find the right dosing for each person. There are prescribing parameters for best success as well as to monitor for known side effects and contraindications that require communication with your physician to make sure the drug is working safely for each user.3

Side effects and warnings

Osmolex ER is contraindicated for people with low creatinine levels or major psychotic disorders. Drinking alcohol is not recommended when taking Osmolex ER as it may increase the effects on the central nervous system causing people to feel dizzy, light-headed, or more sleepy. There are also warnings for users and physicians. In some people, daytime somnolence is increased. Falling asleep during the day in the middle of regular activities, like having a conversation or driving a car, has been noted. Dizziness and orthostatic hypertension should be monitored, especially during dose titration (adjustments).3

There are some psychological side effects that should also be considered. These include a risk of exacerbating psychosis, so monitoring for hallucinations, suicide, and depression is especially important during new dosing. Communication between physician and caregivers is essential because the person with Parkinson’s may not always be aware of symptomatic side effects of Osmolex ER.

Like with any medication, always talk to a doctor before stopping or modifying your prescribed dose. Make sure your physician is aware of all the other medications and supplements you are taking when talking about Osmolex ER. This is important to avoid adverse drug interactions.

Not yet available on the market

Osmolex ER is not yet on the market. Osmotica is finalizing production and marketing plans to make sure patients and physicians have access as soon as possible.3 The roll-out plan for the new drug will contain an educational and marketing plan for prescribers.

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