– Phase 3 study demonstrated statistically significant and clinically meaningful improvement compared to placebo at primary endpoint –
MARLBOROUGH, MA, USA I February 27, 2017 I Sunovion Pharmaceuticals Inc. (Sunovion) today announced that its Phase 3 clinical study evaluating Latuda® (lurasidone HCl) in children and adolescents aged 10 to 17 years with depression associated with bipolar I disorder (bipolar depression) met its primary endpoint. LATUDA is currently indicated in the U.S. for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate in adults and for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years.
“Children and adolescents with bipolar depression often experience significant changes in mood and functioning that can affect performance in school and relationships with peers and family,” said Kiki Chang, M.D., Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center. “Early identification, accurate diagnosis and proper treatment are critical in helping children and their families effectively manage this disorder.”
“There are few treatment options for bipolar depression in this population,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We are encouraged by these topline results that demonstrate the potential of LATUDA to help children and adolescents with bipolar depression.”
In the six-week, randomized, double-blind, placebo-controlled, parallel-group, multi-regional study, children and adolescents aged 10 to 17 years with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo. The primary efficacy endpoint was change from baseline to Week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score, and the key secondary endpoint was change from baseline to Week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score for depression. Treatment with LATUDA was associated with statistically significant and clinically meaningful improvement in symptoms of bipolar depression compared to placebo at both the primary and key secondary endpoints at Week 6.
LATUDA was generally well tolerated with minimal effects on weight and metabolic parameters. Adverse events (AEs) included nausea, somnolence, weight increased, vomiting, dizziness, insomnia and decreased appetite.
Full results are being analyzed and will be presented at upcoming scientific meetings. Sunovion intends to submit a supplemental New Drug Application (sNDA) to the FDA in 2017 for LATUDA as a treatment for children and adolescents aged 10 to 17 years with bipolar depression.
About Bipolar Disorder
Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania.1,2 It affects approximately 12.6 million adults in the United States.3,4 It often begins during adolescence and can be difficult to diagnose.5 Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States.6 Symptoms of bipolar disorder in children and adolescents can be severe.7
Bipolar disorder is the sixth leading cause of disability worldwide.8 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.9 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.10 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,11,12 and are associated with increased risk of suicide and direct and indirect health care costs.13,14
About LATUDA
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 monotherapy study and a 6-week 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 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 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 commercialization of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCl) 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, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, 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.
SOURCE: Sunovion Pharmaceuticals
Post Views: 79
– Phase 3 study demonstrated statistically significant and clinically meaningful improvement compared to placebo at primary endpoint –
MARLBOROUGH, MA, USA I February 27, 2017 I Sunovion Pharmaceuticals Inc. (Sunovion) today announced that its Phase 3 clinical study evaluating Latuda® (lurasidone HCl) in children and adolescents aged 10 to 17 years with depression associated with bipolar I disorder (bipolar depression) met its primary endpoint. LATUDA is currently indicated in the U.S. for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate in adults and for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years.
“Children and adolescents with bipolar depression often experience significant changes in mood and functioning that can affect performance in school and relationships with peers and family,” said Kiki Chang, M.D., Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center. “Early identification, accurate diagnosis and proper treatment are critical in helping children and their families effectively manage this disorder.”
“There are few treatment options for bipolar depression in this population,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We are encouraged by these topline results that demonstrate the potential of LATUDA to help children and adolescents with bipolar depression.”
In the six-week, randomized, double-blind, placebo-controlled, parallel-group, multi-regional study, children and adolescents aged 10 to 17 years with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo. The primary efficacy endpoint was change from baseline to Week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score, and the key secondary endpoint was change from baseline to Week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score for depression. Treatment with LATUDA was associated with statistically significant and clinically meaningful improvement in symptoms of bipolar depression compared to placebo at both the primary and key secondary endpoints at Week 6.
LATUDA was generally well tolerated with minimal effects on weight and metabolic parameters. Adverse events (AEs) included nausea, somnolence, weight increased, vomiting, dizziness, insomnia and decreased appetite.
Full results are being analyzed and will be presented at upcoming scientific meetings. Sunovion intends to submit a supplemental New Drug Application (sNDA) to the FDA in 2017 for LATUDA as a treatment for children and adolescents aged 10 to 17 years with bipolar depression.
About Bipolar Disorder
Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania.1,2 It affects approximately 12.6 million adults in the United States.3,4 It often begins during adolescence and can be difficult to diagnose.5 Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States.6 Symptoms of bipolar disorder in children and adolescents can be severe.7
Bipolar disorder is the sixth leading cause of disability worldwide.8 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.9 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.10 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,11,12 and are associated with increased risk of suicide and direct and indirect health care costs.13,14
About LATUDA
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 monotherapy study and a 6-week 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 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 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 commercialization of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCl) 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, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, 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.
SOURCE: Sunovion Pharmaceuticals
Post Views: 79
