Sunovion Pharmaceuticals Inc.Announces Publication Of Data Evaluating The Long-Term Safety And Tolerability Of Latuda (Lurasidone Hcl) In The Treatment Of Bipolar Depression

Results from the first long-term study to evaluate the effects of treatment in patients with bipolar depression showed LATUDA was well-tolerated with minimal effects on weight and metabolic parameters

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced the publication in the journal Depression and Anxiety of results from a six-month, open-label extension study that evaluated the long-term safety, tolerability and effectiveness of Latuda® (lurasidone HCI) when used either as monotherapy or as adjunctive therapy in combination with lithium or valproate in adults with major depressive episodes associated with bipolar I disorder (bipolar depression).

“The safety and efficacy of LATUDA in treating bipolar depression has been well established in short-term trials, and results from this open-label extension study provide additional evidence to support its safety, tolerability and effectiveness over the long-term.”

The study found that six months of once-daily treatment with flexibly-dosed LATUDA (20–120 mg), following a six-week, placebo-controlled treatment period, was well-tolerated with minimal change in weight and metabolic parameters.

Secondary analyses also showed that six months of open-label LATUDA treatment was associated with sustained improvement in depressive symptoms based on observed case data over time and assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).

LATUDA is an atypical antipsychotic agent indicated in the United States for the treatment of adult patients with bipolar depression, both as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of adult patients with schizophrenia.

“Bipolar disorder is a chronic illness and the depressive phase, also referred to as bipolar depression, can be particularly debilitating,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion. “The safety and efficacy of LATUDA in treating bipolar depression has been well established in short-term trials, and results from this open-label extension study provide additional evidence to support its safety, tolerability and effectiveness over the long-term.”

This six-month, open-label extension of three six-week, placebo-controlled studies was designed to evaluate the long-term safety and tolerability of LATUDA in patients with bipolar depression. A secondary aim was to evaluate the effectiveness of LATUDA in maintaining improvement in depressive symptoms.

The study enrolled patients who had recently completed one of three six-week, double-blind trials evaluating the safety and efficacy of LATUDA compared to placebo for the treatment of bipolar depression, either as monotherapy or as adjunctive therapy with lithium or valproate. Eight hundred thirteen patients were treated for up to six months (monotherapy, 38.9%; adjunctive therapy, 61.1%) with flexible doses of LATUDA, ranging from 20–120 mg/day. Five hundred fifty-nine patients completed the extension study, with 6.9% and 9.0% in the monotherapy and adjunctive therapy groups, respectively, discontinuing due to an adverse event. The results for the monotherapy and adjunctive therapy groups, respectively, for changes from double-blind baseline to month six were as follows based on last observation carried forward (LOCF analysis):

  • Mean changes in weight: +0.85 and +0.88 kg
  • Median changes in total cholesterol: 0.0 and +2.0 mg/dL
  • Median changes in triglycerides: +5.0 and +5.0 mg/dL
  • Median changes in glucose: -1.0 and 0.0 mg/dL

“While the major focus of most clinical trials is on the treatment of acute episodes in bipolar disorder, the main concern for patients in our clinics is on sustained improvement and their fear of recurrences,” said John Beyer, M.D., Professor of Psychiatry and Behavioral Sciences at Duke University School of Medicine and Director of Duke Mood and Anxiety Disorder Clinic. “This extension study provides evidence that LATUDA may have a role in the clinician’s armamentarium for sustained treatment.”

About Bipolar Depression

Bipolar disorder, a mental health condition that requires long-term treatment and is characterized by debilitating mood swings,1 affects approximately 12.6 million adults in the United States.2,3 It is among the top 10 leading causes of disability in the United States.4,5 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; often individuals have one or more depressive episodes.6 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, most individuals with bipolar disorder spend more time in the depressive phase.7 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,8,9 and are associated with increased risk of suicide and direct and indirect healthcare costs.10,11

About LATUDA

LATUDA is FDA-approved to treat adult patients with:

  • Major depressive episodes associated with bipolar I disorder (bipolar depression) when used alone or with lithium or valproate
  • Schizophrenia

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 the treatment of adult patients with schizophrenia was established in five 6-week controlled studies. 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.

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; and nausea.

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

Please see Important Safety Information, including Boxed Warnings, below and full Prescribing Information at www.LATUDA.com.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS

  • Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for treating elderly patients with dementia-related psychosis.
  • Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Patients, families, and caregivers should pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for patients under the age of 18 years.

LATUDA can cause serious side effects, including stroke that can lead to death, which can happen in elderly people with dementia who take medicines like LATUDA.

Neuroleptic malignant syndrome (NMS) is a rare but very serious condition that can happen in people who take antipsychotic medicines, including LATUDA. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have some or all of these symptoms: high fever, excessive sweating, rigid muscles, confusion, or changes in your breathing, heartbeat, or blood pressure.

Tardive dyskinesia (TD) is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD may also start after you stop taking LATUDA.

Increases in blood sugar can happen in some people who take LATUDA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start LATUDA and during therapy. Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: feel very thirsty, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick to your stomach, feel confused, or your breath smells fruity.

Increases in triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with LATUDA. You may not have any symptoms, so your healthcare provider may decide to check your cholesterol and triglycerides during your treatment with LATUDA.

Some patients may gain weight while taking LATUDA. Your doctor should check your weight regularly.
Tell your doctor if you experience any of these:

  • feeling dizzy or light-headed upon standing,
  • decreases in white blood cells (which can be fatal),
  • trouble swallowing.

LATUDA and medicines like it may raise the level of prolactin. Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence.

Tell your healthcare provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures.

Tell your healthcare provider if you experience prolonged, abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia.

LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how LATUDA affects you.

LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm.

Avoid eating grapefruit or drinking grapefruit juice while you take LATUDA since these can affect the amount of LATUDA in the blood.

Tell your healthcare provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with LATUDA. Tell your healthcare provider if you are allergic to any of the ingredients of LATUDA or take certain medications called CYP3A4 inhibitors or inducers. Ask your healthcare provider if you are not sure if you are taking any of these medications.

Avoid drinking alcohol while taking LATUDA.

Tell your healthcare provider if you are pregnant or if you are planning to get pregnant. Avoid breastfeeding while taking LATUDA.

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; and nausea.

These are not all the possible side effects of LATUDA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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 spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company 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 HCI), and most recently 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 @Sunovion and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan. Sumitomo Dainippon Pharma aims to produce 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 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM is used under license from BIAL.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
© 2016 Sunovion Pharmaceuticals Inc.

For a copy of this release, visit Sunovion’s web site at www.sunovion.com

References

1 Swann, AC. Long-term treatment in bipolar disorder. Journal of Clinical Psychiatry. 2005; 66(1):7-12.
2 National Institute of Mental Health. Bipolar Disorder. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml. Accessed March 17, 2016.
3 “Bipolar Disorder.” Decision Resources. Table 2-2. Burlington, MA. December 2013.
4 National Alliance on Mental Illness. The Impact and Cost of Mental Illness: The Case of Bipolar Disorder. [Internet]. Available from: http://www2.nami.org/Template.cfm?Section=members&template=/ContentManagement/ContentDisplay.cfm&ContentID=42734. Accessed March 17, 2016.
5 National Alliance on Mental Illness. A Primer on Depressive, Bipolar and Anxiety Illnesses: Facts for Policymakers. [Internet]. Available from: http://www2.nami.org/walkTemplate.cfm?Section=NAMIWALKS&template=/ContentManagement/ContentDisplay.cfm&ContentID=42736. Accessed March 17, 2016.
6 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC, American Psychiatric Association, 2000.
7 The Depression and Bipolar Support Alliance. Mood Disorders and Different Kinds of Depression. [Internet]. Available from: http://www.dbsalliance.org/site/PageServer?pagename=education_bipolar_types. Accessed March 17, 2016.
8 Huxley N, Baldessarini RJ. Disability and Its Treatment in Bipolar Disorder Patients. Bipolar Disorder. 2007; 9(1-2):183-96.
9 Calabrese JR, Hirschfeld RM, Frye MA, Reed ML. Impact Of Depressive Symptoms Compared With Manic Symptoms In Bipolar Disorder: Results Of A U.S. Community-Based Sample. Journal of Clinical Psychiatry. 2004; 65(11):1499-504.
10 Parker G, McCraw S, Hadzi-Pavlovic D, Fletcher K. Costs Of The Principal Mood Disorders: A Study Of Comparative Direct And Indirect Costs Incurred By Those With Bipolar I, Bipolar II And Unipolar Disorders. Journal of Affective Disorders. 2012; 149(1-3):46-55. (ePub).
11 Leverich GS, Altshuler LL, Frye MA, et al. Factors Associated With Suicide Attempts In 648 Patients With Bipolar Disorder In The Stanley Foundation Bipolar Network. Journal of Clinical Psychiatry. 2003; 64(5):506-15.

Contacts

Sunovion Pharmaceuticals Inc.
Kristina Coppola, 508-787-4368
Sr. Manager, Portfolio Communications
kristina.coppola@sunovion.com

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