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.

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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.

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