FDA OKs Extended-Release Amantadine (Osmolex ER) for Parkinson's

Megan Brooks


February 20, 2018

The US Food and Drug Administration (FDA) has approved amantadine extended-release tablets (Osmolex ER, Osmotica Pharmaceutical) for the treatment of Parkinson's disease and drug-induced extrapyramidal symptoms in adults, the company has announced.

Osmolex ER tablets are a proprietary formulation containing a combination of immediate-release and extended-release amantadine using Osmotica's patented Osmodex technology.  Taken once daily in the morning, the Osmolex ER tablet releases amantadine throughout the day.

Osmolex ER provides "a new treatment option for those patients suffering from Parkinson's disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines," Osmotic CEO Brian Markison said in a news release.

The tablets are available in three dosing options (129-mg, 193-mg, and 258-mg tablets). The initial dosage is 129 mg orally once daily in the morning.  The dosage may be increased in weekly intervals to a maximum daily dose of 322 mg once daily in the morning.

The drug is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2.

Complete prescribing information is available online.

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