In the premarket session, Osmotica Pharmaceuticals plc (Nasdaq: OSMT) sank -27.41% to $ 3.93 after The U.S. Food and Drug Administration has issued a Complete Response Letter regarding Osmotica Pharmaceutical’s NDA seeking approval of the investigational agent arbaclofen extended-release tablets to treat the spasticity resulting from multiple sclerosis.
In its most recent NDA amendment, the Company failed to justify the change from the initial baseline to Day 84 in TNmAS-MAL scores between groups consisting of arbaclofen 40 mg and placebo. In its clinical review letter, the FDA proposed several changes to the product, including the requirement that the Company conducts new clinical studies to provide substantial evidence of arbaclofen’s efficacy.
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