Sunovion Announces Positive Clinical Study Results For Latuda (Lurasidone HCL) In Adolescents With Schizophrenia
- Study results show that LATUDA is effective and generally well tolerated in adolescents ages 13 to 17 years -
- Data support a supplemental New Drug Application (sNDA) filing currently under review -
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced the results of a study evaluating Latuda® (lurasidone HCI) for the treatment of schizophrenia in adolescents ages 13 to 17 years. Patients taking fixed doses of LATUDA 40 mg/day or 80 mg/day in the 6-week study showed statistically significant and clinically meaningful improvement in symptoms of schizophrenia compared to placebo treatment. LATUDA was also generally well tolerated, with limited effects on weight and metabolic parameters. The study results will be presented today at a medical conference in New York, New York.
“Early onset schizophrenia can be devastating, and we need treatment options that balance efficacy with a tolerable side effect profile, particularly when it comes to weight gain and metabolic changes”
“Early onset schizophrenia can be devastating, and we need treatment options that balance efficacy with a tolerable side effect profile, particularly when it comes to weight gain and metabolic changes,” said Robert Findling, M.D., M.B.A., Vice President of Psychiatric Services and Research at the Kennedy Krieger Institute, Director of Child and Adolescent Psychiatry at Johns Hopkins and one of the study authors. “These results show that LATUDA may address an unmet need for adolescents and families faced with this complex lifelong illness.”
These data support the supplemental New Drug Application (sNDA), which has been accepted by the U.S. Food and Drug Administration (FDA). Acceptance of the sNDA does not mean that LATUDA will be approved by the FDA for the treatment of adolescents with schizophrenia. 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 and for the treatment of schizophrenia in adults.
In the randomized, double-blind, placebo-controlled six-week study, adolescent patients were randomized to receive fixed doses of LATUDA 40 mg/day, LATUDA 80 mg/day or placebo. The primary efficacy endpoint was change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6, and the key secondary endpoint was change from baseline in Clinical Global Impression-Severity (CGI-S) scale at Week 6, which assessed global severity of illness.
LATUDA was associated with a statistically significant reduction in PANSS total scores and CGI-S scores at Week 6 compared to placebo for both dose groups, with a placebo-adjusted, least-squares (LS) mean improvement as follows:
- LATUDA 40 mg/day: improvement of -8.0 (adjusted p-value<0.001, effect size=0.51) in PANSS total scores; improvement of -0.47 (adjusted p-value<0.001, effect size=0.49) in CGI-S scores.
- LATUDA 80 mg/day: improvement of -7.7 (adjusted p-value<0.001, effect size=0.48) in PANSS total scores; improvement of -0.42 (adjusted p-value=0.002, effect size=0.45) in CGI-S scores.
LATUDA was generally well tolerated in both dose groups. The rate of study discontinuation due to adverse events (AEs) was higher in the placebo vs. LATUDA group at 8.0 percent vs 3.7 percent, respectively. The most common AEs with an incidence = 5 percent in either LATUDA group and at least twice the rate of placebo for LATUDA 40 mg/day, 80 mg/day and placebo, respectively, were somnolence* (15.5 percent, 13.5 percent, 7.1 percent), nausea (12.7 percent, 14.4 percent, 2.7 percent), akathisia (9.1 percent, 8.7 percent, 1.8 percent) and vomiting (8.2 percent, 6.7 percent, 1.8 percent).
“We are pleased that the efficacy and tolerability profile of LATUDA for patients with schizophrenia was similar in adolescents to that previously seen in adults across multiple studies,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion. “We believe that LATUDA, if approved, will be an important new therapeutic option for adolescents with schizophrenia.”
Additional data from this study will also be presented, showing that LATUDA was associated with minimal changes in weight and metabolic parameters. Specific results included:
- Weight†: +0.17 kg for LATUDA 40 mg/day, +0.49 kg for LATUDA 80 mg/day and +0.05 kg for placebo.
- Cholesterol‡: -4.0 mg/dL for LATUDA 40 mg/day, -2.0 mg/dL for LATUDA 80 mg/day and -7.0 mg/dL for placebo.
- Triglycerides‡: -2.0 mg/dL for LATUDA 40 mg/day, +7.0 mg/dL for LATUDA 80 mg/day and -2.0 mg/dL for placebo.
- Glucose‡: 0.0 mg/dL for LATUDA 40 mg/day, +1.0 mg/dL for LATUDA 80 mg/day and 0.0 mg/dL for placebo.
- Prolactin‡: In male patients was +0.8 ng/mL for LATUDA 40 mg/day, +1.0 ng/mL for LATUDA 80 mg/day and 0.0 ng/mL for placebo; in female patients was +0.6 ng/mL for LATUDA 40 mg/day, +4.4 ng/mL for LATUDA 80 mg/day and +0.7 ng/mL for placebo
* Somnolence includes adverse event terms: hypersomnia, sedation,
somnolence and hypersomnolence
† LS mean change at Week 6
‡ Median change at Week 6 last observation carried forward (LOCF) endpoint
Schizophrenia is a chronic, serious and often severely disabling brain disorder. Symptoms such as hallucinations and delusions usually start between ages 16 and 30.1 It can be difficult to diagnose schizophrenia in adolescents. A combination of factors can predict schizophrenia in up to 80 percent of youth who are at high risk of developing the illness. These factors include isolating oneself and withdrawing from others, an increase in unusual thoughts and suspicions, and a family history of psychosis.2 Concerns related to antipsychotic treatment tolerability also appear to be greater for children and adolescents compared to adults.3 Adolescent patients seem particularly vulnerable to antipsychotic-induced weight gain, metabolic disturbance and endocrine changes.3,4
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
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 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, 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, 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 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
1 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed August 2016.
2 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed August 2016.
3 Vitiello B, et al. Eur Neuropsychopharmacol. 2009;19(9):629-635.
4 Correll CU, Carlson HE. J Am Acad Child Adolesc Psychiatry. 2006;45(7):771-791.