Thursday, April 19, 2018

FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions


In continuation of my update on amantadine

Osmotica Pharmaceutical US LLC, announced the  U.S. Food and Drug Administration (FDA) has approval 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.

“The FDA’s approval of Osmolex ER provides a new treatment option for those patients suffering from Parkinson’s disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines. We are eager to make Osmolex ER available to physicians and patients in the U.S.,” stated Brian Markison, Chief Executive Officer of Osmotica.
“We are currently finalizing our plans to commercialize the product and ensure patients and providers have access as soon as possible. We believe that the approved indications and compelling value proposition will be important factors in physician adoption and marketing of Osmolex ER,” added Markison.
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.
Osmolex ER is protected by three formulation patents with protection extending through March 2030, with additional patent applications pending.

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