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Ontinua ER

Generic name: arbaclofen
Treatment for: Spasticity, Multiple Sclerosis

Osmotica Announces FDA Acceptance of Filing for Ontinua ER for Alleviation of Spasticity Resulting from Multiple Sclerosis

MARIETTA, Ga.--(BUSINESS WIRE) September 28, 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 New Drug Application (NDA) for Ontinua ER has been accepted for filing by the U.S. Food and Drug Administration (FDA).

The application covers the use of Ontinua ER (arbaclofen) extended-release tablets for alleviation of spasticity associated with multiple sclerosis. Multiple Sclerosis is the most common inflammatory disorder of the central nervous system. More than 2.5 million patients suffer from multiple sclerosis worldwide with 400,000 in the US. Of the 2.5 million patients, 50% suffer from spasticity.

Spasticity refers to feelings of stiffness and a wide range of involuntary muscle spasms. Spasticity may be as mild as tightness of muscles or may be so severe as to produce painful, uncontrollable spasms of extremities, usually of the legs. Treatment of spasticity is needed to prevent the deterioration in hips, knees, ankles, shoulders and elbows.

“Ontinua ER given twice a day was shown to meet the co-primary endpoints of the Modified Ashworth Scale and the Clinical Global Impression of Change in the clinical study,” said Mark Stacy, MD, Vice Dean for Clinical Research, Duke University School of Medicine and head of the Osmotica’s Scientific Advisory Board. “Ontinua ER represents a great treatment option for MS patients with spasticity, and we look forward to bringing this therapy to patients.”

“Using our proprietary OsmodexTM technology, we have developed Ontinua ER, a tablet that is intended to treat spasticity in patients with Multiple Sclerosis,” said Praveen Tyle, PhD, President and CEO of Osmotica Pharmaceutical Corp. We believe this product represents an innovative option for clinicians and physicians and we look forward to bringing this therapy to our patients upon regulatory approval.”

Osmotica’s proprietary technology platform OsmodexTM was developed in the 1980’s and has been used by Osmotica and its founders to commercialize multiple products globally with aggregate sales in excess of $2.0 billion. The proven OsmodexTM platform is the core patent protected technology enabling the development of Ontinua ER, Osmolex ER and Osmotica’s robust early development pipeline. Osmotica Pharmaceutical and its related companies form an international group of companies with principal operations located in the United States, Argentina and Hungary.

For more information on the Company, please visit Osmotica’s website at www.osmotica.com.

Source: Osmotica Pharmaceutical Corp.

Posted: September 2015

Ontinua ER (arbaclofen) FDA Approval History

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