Posted by Michael Wonder on 19 Feb 2018
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
19 February 2018 - Osmotica Pharmaceutical announced today that the U.S. FDA has approved Osmolex ER, an amantadine extended release tablet, for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms are known side effects of many common medications.
Osmolex ER tablets, a proprietary drug formulation containing a combination of immediate release and extended release amantadine utilizing Osmotica’s patented Osmodex technology, represents a new once-a-day approach to the treatment of Parkinson’s disease and drug-induced involuntary movements in adults. The Osmolex ER tablet is taken once-daily in the morning, releasing amantadine throughout the day. Physicians have three dosage options with 129 mg, 193 mg and 258 mg tablets, with a maximum daily dose of 322 mg, providing them with dosing flexibility for each patient.
