FDA Accepts Ontinua ER NDA
Osmotica Pharmaceutical announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Ontinua ER (arbaclofen) extended-release tablets for alleviation of spasticity associated with multiple sclerosis (MS).
Spasticity associated with MS affects about 50% of more than 2.5 million patients suffering from MS worldwide. Treatment of spasticity is necessary to prevent the deterioration in hips, knees, ankles, shoulders and elbows.
Clinical study showed that Ontinua ER, which utilizes Osmotica's proprietary drug delivery technology Osmodex, met its co-primary endpoints of the Modified Ashworth Scale and the Clinical Global Impression of Change.
For more information visit Osmotica.com.