FDA Approves Once-Daily Osmolex ER for Parkinson’s Disease Treatment

Tablets are also indicated to treat drug-induced extrapyramidal reactions

The FDA has approved an amantadine extended-release tablet (Osmolex ER, Osmotica Pharmaceutical) for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adults. Extrapyramidal symptoms are known side effects of many common medications.

Osmolex ER tablets are a proprietary drug formulation containing a combination of immediate-release and extended-release amantadine utilizing Osmotica’s patented Osmodex technology. The 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.

Osmolex ER is protected by three formulation patents with protection extending through March 2030, with additional patent applications pending.

Source: Osmotica; February 19, 2018.