Osmotica Pharmaceuticals (NASDAQ:OSMT) has resubmitted its New Drug Application (NDA) to the FDA for arbaclofen extended release tablets for the alleviation of spasticity in multiple sclerosis (MS) patients.
This resubmission also includes the full results of the second Phase 3 efficacy study. The safety and efficacy results from these studies, together with the entire data package from clinical development program, support the clinical significance of arbaclofen ER as a potential treatment for MS spasticity.
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