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Osmotica Pharmaceuticals plc Receives Complete Response Letter from U.S. Food and Drug Administration for Arbaclofen Extended Release Tablets Osmotica Holdings US LLC Bridgewater, New Jersey, UNITED STATES
BRIDGEWATER, N.J., Dec. 29, 2020 (GLOBE NEWSWIRE) Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”) today announced that the U.S. Food and Drug Administration (“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 reco