June 30, 2020 / 11:30 AM / 12 days ago

BRIEF-Osmotica Submits Amended NDA For Arbaclofen Extended Release Tablets To FDA

June 30 (Reuters) - Osmotica Pharmaceuticals PLC:

* OSMOTICA PHARMACEUTICALS US LLC SUBMITS AMENDED NDA FOR ARBACLOFEN EXTENDED RELEASE TABLETS TO U.S. FOOD AND DRUG ADMINISTRATION

* OSMOTICA PHARMACEUTICALS PLC - DEMONSTRATED EFFICACY, TOLERABILITY AND ONE-YEAR SAFETY RESULTS ON 80 MG/DAY

* OSMOTICA PHARMACEUTICALS PLC - RESULTS OF STUDY OS440-3004 REVEALED A STATISTICALLY SIGNIFICANT IMPROVEMENT FROM BASELINE

* OSMOTICA PHARMACEUTICALS PLC - SUBJECTS DOSED WITH 80 MG/DAY (40 MG GIVEN TWICE A DAY) ALSO DERIVED SIGNIFICANT CLINICAL BENEFIT

* OSMOTICA PHARMACEUTICALS PLC - MEAN CLINICAL GLOBAL IMPRESSION OF CHANGE SCORE FOR ARBACLOFEN ER WAS NOT SIGNIFICANTLY BETTER THAN PLACEBO

* OSMOTICA PHARMACEUTICALS PLC - SUBJECTS TREATED WITH ARBACLOFEN ER TABLETS DID NOT SHOW A MEAN WORSENING OF CGIC SCORES AFTER TREATMENT Source text for Eikon: Further company coverage:

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