MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced the publication of results in the Journal of Clinical Psychiatry from a randomized, double-blind, placebo-controlled study that investigated the efficacy of low-dose LATUDA (20 mg/day) in adults with schizophrenia (primary endpoint). The study also investigated the effect of dose escalation in adults with schizophrenia who demonstrated inadequate initial response to standard dose Latuda® (lurasidone HCI).
The study found that LATUDA 20 mg/day was not associated with significant improvement in psychotic symptoms in adult patients with schizophrenia, indicating that the lowest effective dose of LATUDA for the treatment of schizophrenia is 40 mg/day, consistent with current prescribing information. In addition, the study found that in adults with schizophrenia who did not respond to two weeks of treatment with LATUDA 80 mg/day, increasing the dose to 160 mg/day resulted in significant symptom improvement over the next four weeks when compared to those who continued taking LATUDA 80 mg/day.
“In the treatment of patients with schizophrenia, an important clinical concern is how to address early non-response to therapy,” said John Kane, M.D., Chairman, Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, and one of the study authors. “These study data provide clinically important evidence to inform decisions about when to increase medication dosage.”
“This novel study design, which re-randomizes hospitalized patients with schizophrenia who initially did not respond to treatment, minimizes the inherent bias seen in dose escalation studies conducted to date,” said Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry & Behavioral Sciences, New York Medical College and one of the study authors. “The results of this study have significant implications for clinical practice as they provide evidence that dose escalation with LATUDA in non-responders can improve patient outcomes.”
In this study, hospitalized patients with acute schizophrenia were assigned to treatment with LATUDA 20 mg/day, LATUDA 80 mg/day or placebo. Non-responders to LATUDA 80 mg/day, specifically those who had a Positive and Negative Syndrome Scale (PANSS) score decrease of <20% at two weeks, were re-randomized to LATUDA 80 mg/day or LATUDA 160 mg/day for the remaining four weeks of the study. The primary outcome measure was change from baseline to Week 6 in PANSS total score. Results were as follows:
- Low dose (LATUDA 20 mg/day): LS mean change from baseline to Week 6 in PANSS total score was not significantly different compared with patients receiving placebo (–17.6 vs. –14.5; p=0.26, effect size=0.19).
- Early non-responders (LATUDA 80 mg/day vs. LATUDA 160 mg/day): least square (LS) mean change from Week 2 to Week 6 in PANSS total score was significantly greater for patients whose dose was increased to LATUDA 160 mg/day compared with that for patients who continued receiving LATUDA 80 mg/day (–16.6 vs. –8.9; p<0.05, effect size=0.52).
LATUDA was generally well-tolerated. Serious treatment-emergent adverse events (TEAEs) were reported in three patients in the LATUDA 20 mg/day group, four patients in the early non-responder LATUDA 80 mg/day group, one patient in the early non-responder LATUDA 160 mg/day group and eight patients in the placebo group. In early non-responders, patients whose dose was increased to LATUDA 160 mg/day reported a greater incidence of anxiety, abdominal discomfort, akathisia, insomnia, and somnolence compared with patients who continued on LATUDA 80 mg/day. LATUDA demonstrated low rates of change in weight and metabolic parameters.
“Few randomized, placebo-controlled studies have evaluated dose escalation as a strategy for addressing early nonresponse to antipsychotic therapy,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion. “Sunovion is pleased to contribute to the important medical discourse on how to manage patients with schizophrenia who do not respond to initial treatment.”
These data were presented at multiple U.S. and international scientific meetings in 2015.
About Schizophrenia
Schizophrenia is a chronic, serious and often severely disabling brain disorder that affects approximately 1 in 100 American adults (about 2.4 million people) in the United States.1 It is characterized by symptoms such as hallucinations, delusions, disorganized thinking, lack of emotion and lack of energy, as well as problems with memory, attention and the ability to plan, organize and make decisions.2
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 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
References
1 Regier DA, Narrow WE, Rae DS,
Mandercheid RW, Locke B2, Goodwin, FK. The de Facto US Mental and
Addictive Disorders Service System. Arch Gen Psychiatry. 1993;50:85-94.
Calculated by extrapolating from the 2008 United States Census Bureau
population estimates.
2 NAMI, Schizophrenia. Available
at: http://www.nami.org/Template.cfm?Section=By_Illness&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=54&ContentID=23036.
Accessed May 15, 2013.
