FDA Approves Extended Release Amantadine for Parkinson Disease, Extrapyramidal Reactions

new drug approved
new drug approved
The FDA has approved Osmolex ER for the treatment of Parkinson disease.

Osmotica announced that the Food and Drug Administration (FDA) has approved Osmolex ER (amantadine extended-release tablets) for the treatment of Parkinson disease and for the treatment of drug-induced extrapyramidal reactions in adults.

Osmolex ER tablets combine both immediate- and extended-release amantadine through the Company’s patented Osmodex technology, allowing for once-daily dosing. The approval of Osmolex ER was based on bioavailability studies comparing Osmolex ER to immediate-release amantadine. 

Amantadine is a weak uncompetitive antagonist of the NMDA receptor. The exact mechanism by which it exerts its effects in the treatment of Parkinson disease and drug-induced extrapyramidal reactions is uknown.

Osmolex ER will be available as 129mg, 193mg, and 258mg strength tablets in 30- and 90-count bottles. It is not interchangeable with other amantadine immediate- or extended-release products.

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FDA approves osmotica pharmaceutical’s once-daily OSMOLEX ER™ (amantadine) extended-release tablets for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adults [press release]. Bridgewater, NJ: Osmotica Pharmaceutical. Published February 19, 2018. Accessed February 27, 2018.

This article originally appeared on MPR