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Osmolex ER

Generic name: amantadine hydrochloride
Treatment for: Parkinson's Disease, Extrapyramidal Reaction

Osmotica Announces OS-320 (Osmolex ER), Has Been Awarded Orphan Drug Status by the FDA

MARIETTA, Ga.--(BUSINESS WIRE) July 22, 2015 --Osmotica Pharmaceutical Corp. (privately held), a global specialty pharmaceutical corporation developing best-in-class therapeutics for the treatment of CNS diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for the treatment of levodopa induced dyskinesia (“LID”) for patients with Parkinson’s disease. Osmolex ER, a proprietary drug formulation of Amantadine HCl Extended Release Tablets utilizing Osmotica’s patented Osmodex technology platform, represents a novel approach to the treatment of LID for patients with Parkinson’s disease.

“Receiving Orphan Drug Designation for Osmolex ER in the treatment of LID for patients with Parkinson’s disease is an important milestone for this clinical development program,” commented Osmotica’s Vice President of Global Clinical Development, Dr. Gene Wright. Mark Stacy, MD, Professor of Neurology, Vice Dean for Clinical Research, Department of Neurology, Duke University School of Medicine and Chair of the Osmotica’s Scientific Advisory Board also commented “Osmolex™ ER is a once a day treatment for a highly unmet medical need for Parkinson’s disease patients with Dyskinesia; we look forward to seeing this innovative formulation become available to our patients.” Osmotica anticipates filing the NDA for Osmolex in 2016.

The FDA’s office of Orphan Drug Products grants orphan status to support development of medicines for rare disorders defined as diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides Osmotica with certain benefits, including limited market exclusivity upon regulatory approval when received, and exemption of FDA application fees and tax credits for qualified clinical trials.

In addition to Osmolex ER and a Phase 3 trial recently completed for Ontinua ER, a treatment of spasticity in patients with multiple sclerosis, Osmotica’s pipeline contains multiple CNS projects in early stage development. Osmotica is focused on leveraging its proprietary Osmodex™ Drug Delivery Technology to improve the lives of patients with high unmet needs. Osmotica Pharmaceutical and its related companies form an international group of companies with principal operations located in the United States, Argentina and Hungary.

Source: Osmotica Pharmaceutical Corp.

Posted: July 2015

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