– Full Phase 3 study results have been published in the Journal of the American Academy of Child and Adolescent Psychiatry –

– Post-hoc analysis of positive Phase 3 placebo-controlled study showed six weeks of treatment with LATUDA was associated with significant improvement in a wide range of depressive symptoms in children and adolescents with bipolar depression –

– Interim data from a long-term open-label extension study showed safety and continued efficacy of LATUDA treatment for up to 28 weeks –

MARLBOROUGH, MA, USA I October 27, 2017 I Sunovion Pharmaceuticals Inc. (Sunovion) today announced post-hoc analysis results of a positive Phase 3 placebo-controlled clinical study, as well as interim data from a long-term open-label extension study evaluating Latuda® (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression).

The results showed that six weeks of treatment with LATUDA was associated with statistically significant and clinically meaningful improvement in a wide range of depressive symptoms compared to placebo and that long-term treatment with LATUDA for 28 weeks was well-tolerated and continued to improve depressive symptoms with minimal effect on weight and metabolic parameters in children and adolescents with bipolar depression. Results were presented at a scientific meeting in Washington, D.C., being held October 23-28, 2017.

LATUDA is an atypical antipsychotic agent approved in the United States for the treatment of bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate in adults and for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age).

“Depressive symptoms can be severely debilitating to schoolwork and social activities in children and adolescents living with bipolar disorder, which is recognized as the fourth leading cause of disability among children and adolescents around the world,” said Kiki Chang, M.D., clinical study investigator. “The findings presented today are encouraging, as we need additional treatment options that are well tolerated and can be used on an ongoing basis by children and adolescents who live with bipolar depression.”

“Sunovion is committed to advancing the understanding of serious psychiatric conditions,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “Given the significant impact bipolar depression can have on children and adolescents, it is encouraging to see results that support the potential for LATUDA to be an effective and well-tolerated treatment for this population.”

Sunovion submitted a supplemental New Drug Application (sNDA) for the use of LATUDA in children and adolescents (10 to 17 years of age) with bipolar depression that was accepted for review by the U.S. Food and Drug Administration (FDA) on June 30, 2017.

Phase 3 Study Results

Full Phase 3 study results were recently published in the Journal of the American Academy of Child and Adolescent Psychiatry.1 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. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on the primary efficacy endpoint of change from baseline to Week 6 on the Children’s Depression Rating Scale, Revised (CDRS-R) total score (-21.0 vs. -15.3; effect size = 0.45, p<0.0001).

A post-hoc item analysis of the CDRS-R endpoint presented today showed that LATUDA effectively treated a wide range of depressive symptoms. Compared to placebo, patients randomized to LATUDA demonstrated significantly greater improvement on 13 of the 17 CDRS-R items including social withdrawal, sleep disturbance, listless speech, depressed facial affect, excessive guilt, difficulty having fun, depressed feelings, low self-esteem, excessive weeping, hypoactivity, impaired schoolwork, irritability and appetite disturbance. Changes were not significant between the LATUDA group and placebo group in four CDRS-R items, including excessive fatigue, physical complaints, morbid ideation and suicidal ideation.

LATUDA was generally well-tolerated with minimal effects on weight, metabolic parameters and prolactin levels. Most common adverse events (AEs) with an incidence greater than five percent of LATUDA-treated patients and greater than placebo, included nausea, somnolence, weight increase, vomiting, dizziness and insomnia.

Long-term Open Label Extension Study Interim Analysis Results

A total of 223 participants who completed the six-week trial enrolled in a two-year, open-label, flexible dose, extension study (NCT01914393). Results from an interim analysis showed that among the 155 people who completed 28 weeks of treatment, LATUDA was generally well-tolerated with similar adverse events to those reported during the six-week pivotal study. The most common AEs with an incidence greater than 10 percent were headache (19.7 percent), somnolence (18.5 percent) and nausea (14.3 percent).

Minimal effects were observed on weight, metabolic parameters and prolactin levels. The mean change in weight from double-blind baseline to Week 28 of the open-label extension study was +3.0 kg (as compared to an expected weight gain of +2.3 kg based on normative CDC data). The median change in prolactin from baseline to Week 28 was +2.0 ng/mL for females and +1.6 ng/mL for males. Median change in metabolic parameters from baseline to Week 28 was -4.5 mg/dL in total cholesterol, -3.0 mg/dL in LDL cholesterol, -2.0 mg/dL in triglycerides and +1.0 mg/dL in glucose. No participants in the study had a QTcF≥460 or an increase in QTcF of ≥ 60 milliseconds.

At 28 weeks, participants who were treated with LATUDA throughout the initial six-week trial had continued improvement in the CDRS-R total score in the open-label long-term extension phase (-7.3). Continued improvement in the open-label phase was similarly observed on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) depression score (-1.0).

LATUDA is used to treat patients with:

  • Depressive episodes in bipolar I disorder (bipolar depression) when used alone or with lithium or valproate in adults
  • Schizophrenia in adults and adolescents 13 to 17 years of age

The efficacy of LATUDA was established in a 6-week placebo-controlled monotherapy study and a 6-week placebo-controlled adjunctive therapy study with lithium or valproate in adult patients with bipolar depression. The efficacy of LATUDA in schizophrenia was established in five 6-week placebo-controlled studies in adult patients and one 6-week placebo-controlled study in adolescents (13 to 17 years).

The most common side effects of LATUDA include sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation, and nausea.

LATUDA is available in five tablet strengths: 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established.

About Bipolar Disorder
Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania.2,3 It affects approximately 12.6 million adults in the United States.4,5 Approximately 50 to 60 percent of adults with bipolar disorder experience their first symptoms during adolescence and it can be difficult to diagnose.6,7 Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States.8 Symptoms of bipolar disorder in children and adolescents can be severe and may cause young people to think about death or suicide during depressive episodes.9

Bipolar disorder is the fourth leading cause of disability among children and adolescents worldwide.10 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.3 Bipolar depression refers to the depressive phase of bipolar disorder;1 its symptoms include: depressed mood, loss of interest or pleasure in activities, significant weight loss, insomnia, fatigue, feelings of worthlessness, diminished ability to concentrate and recurrent thoughts of death or suicide attempt.1 When symptomatic, depressive symptoms affect patients more commonly than manic symptoms.11 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,12,13 and are associated with increased risk of suicide and direct and indirect health care costs.14,15

About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Sunovion’s track record of discovery, development and/or commercialization of important therapies has included Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder, Utibron™ Neohaler® (indacaterol/glycopyrrolate) Inhalation Powder, Brovana® (arformoterol tartrate) Inhalation Solution, Latuda® (lurasidone HCI) and Aptiom® (eslicarbazepine acetate).

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

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SOURCE: Sunovion Pharmaceuticals