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
BRIDGEWATER, NJ, USA I February 19, 2018 I Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration (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.
“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.
About OSMOLEX ER
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 and drug-induced extrapyramidal reactions in adults. The OSMOLEX ER tablet is taken once-daily in the morning, releasing amantadine throughout the day. Tablet strength options include 129 mg, 193 mg, and 258 mg with a maximum daily dose of 322 mg.
For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com or call 1-877-482-3788.
Indications
OSMOLEX ER is indicated for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.
About Osmotica Pharmaceutical
Osmotica Pharmaceutical US LLC is a privately-held fully-integrated specialty pharmaceutical company utilizing its proprietary osmotic technology platform, Osmodex®, to develop high-quality branded and generic pharmaceutical products. The Osmotica portfolio includes multiple products currently on the market, and a pipeline of therapeutic drug candidates in various stages of development, addressing central nervous system and neurological movement disorders.
Osmotica has a track record of developing products with successful commercialization strategies around the world and through its U.S. affiliates Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC. Osmotica Pharmaceutical has principal operations located in the United States, Argentina, and Hungary. For more information, please visit the Company’s website at www.osmotica.com.
SOURCE: Osmotica Pharmaceutical
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