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 Ontinua^TM ER. The application covers Ontinua^TM 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.

“Ontinua^TM 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^TM ER represents a great treatment option for MS patients with spasticity, and we look forward to bringing this therapy to patients.”

“Using our proprietary Osmodex^TM technology, we have developed Ontinua^TM 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.”

Osmolex^TM ER is a once/daily drug formulation of Amantadine HCI Extended Release Tablets which uses the company’s Osmodex^TM system, and represents a new strategy to treat patients with Parkinson’s disease who have levodopa induced dyskinesia (“LID”). In July, Osmolex^TM ER was granted orphan exclusivity.

Osmotica’s clinical program for Osmolex^TM 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 Osmolex^TM ER for patients with Parkinson’s disease. The company developed its Osmodex^TM platform in the 1980’s and its products, which are used worldwide, have aggregated sales of over $2.0 billion.