Posted by Michael Wonder on 30 Dec 2020
Osmotica Pharmaceuticals receives complete response letter from U.S. Food and Drug Administration for arbaclofen extended release tablets
29 December 2020 - Osmotica Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the Company's new drug application seeking approval for the investigational agent arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis.
The letter stated that the Company did not provide adequate justification (including in its most recent new drug application 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 outcomes.
The FDA made a number of recommendations in its complete response letter, including that the Company conduct a new trial in order to provide substantial evidence of efficacy of arbaclofen.
