Osmolex ER OK'd for Parkinson's Disease, Drug-Induced Extrapyramidal Reactions

Combines immediate release and extended release amantadine in one tablet
Combines immediate release and extended release amantadine in one tablet

Osmotica announced that the Food and Drug Administration (FDA) has approved Osmolex ER (amantadine extended-release tablets) for the treatment of Parkinson's 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's 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.

For more information call (877) 482-3788 or visit Osmolex.com.