First Atypical Antipsychotic Indicated for the Treatment of Major Depressive Episodes Associated with Bipolar I Disorder (Bipolar Depression) Both as Monotherapy and as Adjunctive Therapy with Either Lithium or Valproate
MARLBOROUGH, Mass.-July 1, 2013 -(BUSINESS WIRE/ME NewsWire)-- Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for the use of Latuda® (lurasidoneHCl) as 1) monotherapy and 2) adjunctive therapywith either lithium or valproate, both to treat adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression).1
“These two approvals represent a significant milestone not only for Sunovion and DSP, but for the millions of Americans who are living with bipolar disorder and struggling to manage the symptoms of bipolar depression,” said Masayo Tada, Representative Director, President and Chief Executive Officer of Dainippon Sumitomo Pharma Co., Ltd. “We look forward to building on the strong foundation started in the United States to bring LATUDA to other markets around the world. In addition, we are preparing for Phase 3 clinical trials for bipolar I disorder (bipolar depression) in Japan, an important market for us, where Phase 3 clinical trials for schizophrenia are already underway. This is part of Sunovion and DSP's ongoing commitment to researching, developing and commercializing new treatments for people with mental illness.”
Two positive double-blind, randomized, placebo-controlled, six-week clinical trials supported the two new indications for LATUDA for the treatment of adult patients with bipolar depression, both as monotherapy (PREVAIL 2) and as adjunctive therapy (added to background treatment with lithium or valproate) (PREVAIL 1). In both studies, the pre-specified primary endpoint was reduction in depressive symptoms, as measured by change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6. The key secondary endpoint (i.e., adjusted for multiple comparisons) was change from baseline in the Clinical Global Impression-Bipolar Version-Severity of Illness (CGI-BP-S) score at Week 6. Other secondary endpoints included changes from baseline at Week 6 in responder rates; rates of remission; Hamilton Anxiety Rating Scale (HAM-A); Sheehan Disability Scale (SDS); Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16); and Quality of Life, Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF).
Both studies showed that treatment with LATUDA resulted in statistically significant reductions in MADRS scores at study endpoint compared to placebo, with significant separation from placebo observed as early as Week 2 of treatment. Additionally, across both studies, patients receiving LATUDA demonstrated statistically significant improvements vs. placebo at Week 6 on secondary endpoints, including CGI-BP-S, responder rates, rates of remission, anxiety symptoms, self-assessment of depression, as well as measures of functionality and quality and enjoyment of life.
The most common adverse reactions (incidence ≥5%, in either dose group, and at least twice the rate of placebo) in patients receiving LATUDA as monotherapy were akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, and anxiety; discontinuation rates due to any adverse reaction were 6.0% for LATUDA and 5.4% for placebo. In adjunctive treatment, the most common adverse reactions in patients receiving LATUDA (incidence ≥5% and at least twice the rate of placebo) were akathisia and somnolence; discontinuation rates due to any adverse reaction were 5.8% for LATUDA and 4.8% for placebo. Patients treated with LATUDA also experienced low rates of change in weight, body mass index (BMI), lipid parameters and measures of glycemic control.
“Patients with bipolar disorder spend the majority of their symptomatic time in the depressed phase of the illness. This phase most commonly results in impaired function, a remarkable decrease in quality of life and may lead to increased risk for attempted suicide,” said Joseph Calabrese, M.D., Professor of Psychiatry and Director of the Mood Disorders Program at University Hospitals Case Medical Center, Case Western Reserve University. “Unfortunately, there are very few treatments specifically approved to treat the symptoms of bipolar depression, which represents a very large unmet medical need for patients and their families.”
“The pharmacological profile of LATUDA, together with preclinical and initial clinical findings, suggested the potential for efficacy in depressive episodes associated with bipolar disorder. Historically, it has been difficult to show efficacy in clinical trials for the treatment of bipolar depression, but we felt strongly it was the right path to take given the high unmet need,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer of Sunovion Pharmaceuticals Inc. “We are pleased that the two new LATUDA indications for monotherapy and adjunctive treatment of bipolar depression are supported by robust evidence demonstrating efficacy and safety.”