Food and Drug Administration Approves Extended-Release Amantadine for Treatment of Parkinson's Disease and Drug-Induced Extrapyramidal Reactions in Adults

Tuesday, February 20, 2018


The Food and Drug Administration (FDA) approved Osmolex ER (Osmotica Pharmaceuticals; Bridgewater, NJ) an extended-release formulation of amantadine for the treatment of Parkinson’s disease (PD) and drug-induced extrapyramidal reactions (EPR) in adults. EPR are a side effect of several antipsychotics and antidepressants.  

Osmolex ER is a proprietary formulation that contains a combination of immediate and extended release amantadine using Osmotica’s patented Osmodex technology.  This formulation allows a daily dose approach for treating PD and EPR. Dosage options include 129 mg, 193 mg and 258 mg tablets, with a maximum daily dose of 322 mg, providing dosing flexibility for each patient. This formulation is contraindicated in patients with a creatinine clearance below 15 mL per minut/1.73m2 and is not recommended for patients with pre-existing psychotic symptoms, which may be exacerbated by Osmolex ER.  Side effects include daytime sleepiness. Patients should be monitored for these adverse reactions of dizziness, hypotension, and suicidal thinking or depressive symptoms, especially after starting OSMOLEX ER or increasing the dose.

 “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 currently finalizing our plans to commercialize the product and ensure patients and providers have access as soon as possible.” stated Brian Markison, Chief Executive Officer of Osmotica.

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