Phase 3 Trial Update of Latuda for Bipolar I Depression
Dainippon Sumitomo Pharma announced results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of Latuda (lurasidone; Sunovion) as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone). On an overall basis in both studies, patients with bipolar I depression treated with Latuda experienced statistically significant improvements in symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), compared to patients taking placebo.
The objective of PREVAIL 1 was to evaluate the efficacy and safety of Latuda when added to either lithium or valproate. Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I depression and remained symptomatic (i.e., MADRS score of ≥20) following at least four weeks of treatment with either lithium or valproate were randomized to six weeks of double-blind treatment with either Latuda 20-120mg/day (N=183) or placebo (N=165), both adjunctive to either lithium or valproate.
The objective of PREVAIL 2 was to evaluate the efficacy and safety of Latuda as monotherapy in patients with bipolar I depression. Patients who met DSM-IV-TR criteria for bipolar I depression and remained symptomatic (i.e., MADRS score of ≥20) were randomized to six weeks of double-blind treatment with Latuda 20-60mg/day (N=166), Latuda 80-120mg/day (N=169), or placebo (N=170).
In both studies, the pre-specified primary endpoint was change from baseline in the MADRS total score at Week 6 study endpoint. The key secondary endpoint was change from baseline in the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score at Week 6.
Primary analyses in both studies showed treatment with Latuda was associated with statistically significant reductions in MADRS scores at the end of each study (Week 6) compared to placebo, with this impact observed as early as Week 2 of treatment. Similarly, across both studies, Latuda was also associated with: statistically significant reductions in CGI-BP-S scores vs. placebo with improvements seen as early as Week 1; statistically significantly higher responder rates (at least 50% reduction in MADRS from baseline for Latuda) compared to placebo; statistically significant reductions compared to placebo in anxiety symptoms assessed by the Hamilton Anxiety Rating Scale (HAM-A) total score; and, statistically significant improvements in social or occupational functioning assessed by the Sheehan Disability Scale (SDS) and in quality of life, assessed by the Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF).
Latuda is an atypical antipsychotic (mixed dopamine D2 and serotonin 5HT2A receptor antagonist) indicated for the treatment of patients with schizophrenia.
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