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Osmotica Pharmaceuticals plc receives Complete Response Letter from FDA for arbaclofen ER tablets to treat spasticity resulting from multiple sclerosis.

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Published:31st Dec 2020
Osmotica Pharmaceuticals plc announced that the FDA has issued a Complete Response Letter (“CRL”) regarding the Company's New Drug Application (“NDA”) seeking approval for the investigational agent arbaclofen extended release ("ER") tablets to treat spasticity resulting from multiple sclerosis. The CRL stated that the Company did not provide adequate justification (including in its most recent NDA amendment) for the statistical analysis of the change from baseline to Day 84 in TNmAS-MAL scores comparing arbaclofen 40 mg to placebo, one of the co-primary endpoints. The FDA made a number of recommendations in its CRL, including that the Company conduct a new study in order to provide substantial evidence of efficacy of arbaclofen.The Company intends to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.
Condition: Multiple Sclerosis
Type: drug

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