MARIETTA, Ga.--(BUSINESS WIRE)--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 OntinuaTM ER has been accepted for filing by the U.S. Food and Drug Administration (FDA).
The application covers the use of OntinuaTM 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.
“OntinuaTM 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. “OntinuaTM 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 OntinuaTM 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 second CNS asset, OsmolexTM ER, a proprietary, once-a-day, drug formulation of Amantadine HCI Extended Release Tablets utilizing Osmotica’s patented OsmodexTM technology, represents a novel approach to the treatment of levodopa induced dyskinesia (“LID”) for patients with Parkinson’s disease. Osmolex ER is designed to be dosed in the morning when patients normally take their first dose of Levodopa. OsmolexTM ER which was granted orphan exclusivity in July 2015 has shown exceptional progress in its clinical development program. Osmotica’s comprehensive clinical program for OsmolexTM ER includes two phase 3 trials evaluating two doses (240mg and 320mg) in 324 aggregate patients. Osmotica intends to file a 505 (b) (2) New Drug Application for OsmolexTM ER in 2016 in order to bring this valuable therapy to patients with Parkinson’s disease.
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 OntinuaTM ER, OsmolexTM 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. This press release is directed to residents of the United States.