Minerva Neurosciences Reports the NDA Submission of Roluperidone to the US FDA for Schizophrenia
Shots:
- The submission was based on (MIN-101C03 & MIN-101C07) studies to evaluate roluperidone (32/64mg) vs PBO for schizophrenia
- In both studies, roluperidone was superior to PBO. The (MIN-101C03) study showed a reduction of negative symptoms of schizophrenia at a 64mg dose in a primary efficacy analysis. In post hoc analysis, significant difference for roluperidone vs PBO & improvements in multiple secondary/exploratory efficacy analyses after 12wks. of DB period, improvements in NSFS @24wk. OL period
- In (MIN-101C07) study, improvement in NSFS in mITT population. In ITT & mITT populations, improvements in NSFS as early as 4 & 8wk. & PSP total score, improvements in NSFS & PSP total score @40wk. OL period & low rate of worsening of positive symptoms in both studies
Ref: GlobeNewswire | Image: Minerva Neurosciences
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