27 May LATUDA Phase 3 Study Demonstrates Improvement in Pediatric and Adolescent Bipolar Depression
MedicalResearch.com Interview with:
Antony Loebel, M.D.
Executive Vice President and Chief Medical Officer
Sunovion, Head of Global Clinical Development
Sumitomo Dainippon Pharma Group
MedicalResearch.com: What is the background for this study? What are the main findings?
In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents (10 to 17 years of age) with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo.The Phase 3 clinical study met its primary endpoint, showing statistically significant and clinically meaningful improvement in symptoms compared to placebo. LATUDA was generally well tolerated, with minimal effects on weight and metabolic parameters.
The primary efficacy endpoint was change from baseline to week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on CDRS-R total score (-21.0 vs. -15.3; effect size = 0.45; p<0.0001) and CGI-BP-S score for depression (-1.49 vs. -1.05; effect size = 0.44; p<0.001).
LATUDA also demonstrated statistically significant improvement on secondary efficacy endpoints.
The most common treatment-emergent adverse events reported for LATUDA compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). LATUDA was associated with no increases in fasting glucose or lipids, and minimal increase in mean weight vs. placebo (+0.74 kg vs. +0.44 kg).
MedicalResearch.com: What should readers take away from your report?
Response: It is encouraging to see the potential for LATUDA to help children and adolescents living with bipolar depression. When bipolar depression strikes in younger years, it can be particularly disabling, so we’re pleased that in this placebo-controlled study, LATUDA improved depressive symptoms without causing significant weight gain or metabolic changes in children and adolescents. These data have been submitted to the U.S. Food and Drug Administration (FDA) to support a supplemental New Drug Application (sNDA).
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: There is a lack of evidence-based studies addressing treatment of bipolar depression in children and adolescents. This study provides substantial evidence that acute bipolar depression in children and adolescents can be effectively treated with lurasidone monotherapy but additional research is needed to establish longer-term effectiveness and safety. Future studies are needed to address the potential for early intervention in bipolar depression to positively impact the longer-term outcomes of individuals with this illness
- I am an employee of Sunovion Pharmaceuticals, the manufacturer of LATUDA.
- Few treatment options are available for children and adolescents living with bipolar depression..
- At Sunovion, we maintain our unwavering commitment to innovation in psychiatry, driven by awareness of the significant medical needs that exist for individuals, their families and communities.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
2017 American Psychiatric Association.(APA) abstract discussing:
Evaluating Latuda® (lurasidone HCl) in Children and Adolescents with Bipolar Depression
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