News FDA Accepts New Drug Application for Osmotica Pharmaceutical’s Ontinua ER for Spasticity in Multiple Sclerosis FDA Accepts New Drug Application for Osmotica Pharmaceutical’s Ontinua ER for Spasticity in Multiple Sclerosis by Patricia Silva, PhD | October 1, 2015 Share this article: Share article via email Copy article link Osmotica Pharmaceutical Corp.Ā recently announced that the FDA accepted its New Drug Application (NDA) for OntinuaTMĀ ER. The application covers OntinuaTMĀ ER (arbaclofen) extended-release tablets for alleviation of spasticity in patients with multiple sclerosis (MS). MS is an inflammatory disease of the central nervous system. In the US, 400,00 people suffer from the disease and, worldwide, MS affects more than 2.3 million individuals. Fifty percent of MS patients suffer from spasticity, which involves feelings of stiffness and muscle spasms. Spasticity can be mild or severe, causing painful and uncontrollable extremities spasms. To prevent the deterioration of knees, shoulders, ankles, elbows and hips, appropriate treatment is necessary. āOntinuaTMĀ 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,ā said Mark Stacy, MD,Ā Vice Dean for Clinical Research, Duke University School of Medicine and head of the Osmoticaās Scientific Advisory Board. āOntinuaTMĀ ER represents a great treatment option for MS patients with spasticity, and we look forward to bringing this therapy to patients.ā āUsing our proprietary OsmodexTMĀ technology, we have developed OntinuaTMĀ ER, a tablet that is intended to treat spasticity in patients with Multiple Sclerosis,ā 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.ā OsmolexTMĀ ER is a once/daily drug formulation of Amantadine HCI Extended Release Tablets which uses the companyās OsmodexTMĀ system, and represents a new strategy to treat patients with Parkinsonās disease who have levodopa induced dyskinesia (āLIDā). In July, OsmolexTMĀ ER was granted orphan exclusivity. Osmoticaās clinical program for OsmolexTMĀ ER comprises two phase 3 clinical trials assessing two doses (240 mg and 320 mg) in a population of 324 patients. In 2016, the company intends to file a 505 (b) (2) New Drug Application for OsmolexTMĀ ER for patients with Parkinsonās disease. The company developed its OsmodexTMĀ platform in the 1980ās and its products, which are used worldwide, have aggregated sales of over $2.0 billion. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags multiple sclerosis, spasticity
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