FDA Accepts New Drug Application for Osmotica Pharmaceutical’s Ontinua ER for Spasticity in Multiple Sclerosis
Osmotica Pharmaceutical Corp. recently announced that the FDA accepted its New Drug Application (NDA) for OntinuaTM ER. The application covers OntinuaTM 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.
“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.”
OsmolexTM ER is a once/daily drug formulation of Amantadine HCI Extended Release Tablets which uses the company’s OsmodexTM system, and represents a new strategy to treat patients with Parkinson’s disease who have levodopa induced dyskinesia (“LID”). In July, OsmolexTM ER was granted orphan exclusivity.
Osmotica’s clinical program for OsmolexTM 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 OsmolexTM ER for patients with Parkinson’s disease. The company developed its OsmodexTM platform in the 1980’s and its products, which are used worldwide, have aggregated sales of over $2.0 billion.