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.
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