Navigation Links
Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

- Improvement Was Noted At Day 3 And All Subsequent Study Visits -

FORT LEE, N.J., June 3 /PRNewswire/ -- Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today that positive results from a phase 2 clinical trial for lurasidone in the treatment of patients with schizophrenia have been published in The Journal of Clinical Psychiatry. This six-week, randomized, double-blind, multicenter, placebo-controlled trial, involving 180 patients with acute schizophrenia, evaluated a single fixed dose of lurasidone 80 mg/day versus placebo. Lurasidone 80 mg/day produced statistically significant improvement versus placebo in both primary and secondary efficacy assessments at all study visits starting at day 3. In addition, lurasidone was generally well-tolerated and was associated with weight and metabolic changes that were similar to placebo. The study is available at

"We are pleased to see the first publication reporting results of a lurasidone placebo-controlled trial in the treatment of patients with acute schizophrenia," said Antony Loebel, M.D., senior author and vice president of clinical research, Dainippon Sumitomo Pharma America, Inc. "Findings from this phase 2 study are consistent with data emerging from the lurasidone global development program, including a recently completed, large phase 3 placebo-controlled trial."

The primary efficacy measure was the BPRSd (Brief Psychiatric Rating Scale-derived). Lurasidone demonstrated significant improvement at Week 6 (LOCF endpoint) compared to placebo on the BPRSd (-8.9 vs. -4.2; p=0.012), as well as on all secondary efficacy measures, including the PANSS (Positive and Negative Syndrome Scale) total score (-14.1 vs. -5.5; p=0.004), PANSS positive subscale (-4.3 vs. -1.7; p=0.006), PANSS negative subscale (-2.9 vs. -1.3; p=0.025) and CGI-S (Clinical Global Impressions-Severity of Illness scale) (-0.6 vs. -0.2; p=0.007) scores.

Lurasidone significantly improved depressive symptoms associated with schizophrenia, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at the study endpoint. The mean changes in MADRS score were -2.9 vs. -0.1 (p=0.019) for lurasidone and placebo, respectively.

Lurasidone's effect on weight (median change 0.9 kg for lurasidone vs. 0.5 kg for placebo), lipids, and glucose was similar to placebo. No clinically important differences were observed between lurasidone and placebo for EPS (assessed using the Simpson-Angus Scale) or symptoms of tardive dyskinesia (assessed using the Abnormal Involuntary Movements Scale). There was a modest but significant worsening at endpoint in akathisia symptoms (assessed using the Barnes Akathisia Scale) for lurasidone versus placebo.

Lurasidone was well-tolerated with generally mild adverse events reported during the trial. The most commonly reported adverse events (reported frequency greater than or equal to 10% among lurasidone subjects) for lurasidone versus placebo were nausea (16% vs. 3%), headache (11.1% vs. 10%), constipation (11.1% vs. 5.6%), vomiting (11.1% vs. 5.6%), dyspepsia (11.1% vs. 3.3%), somnolence (11.1% vs. 3.3%), insomnia (10.0% vs. 3.3%) and sedation (10.0% vs. 4.4%). Lurasidone had a lower overall discontinuation rate (42.2%) compared to placebo (48.8%) with few adverse-event related discontinuations (6.7% and 1.1% for lurasidone and placebo, respectively).

Study Design

This randomized, placebo-controlled, double-blind, multicenter clinical trial conducted in the U.S. evaluated the efficacy of lurasidone 80 mg once daily compared to placebo over six weeks in patients hospitalized for an acute exacerbation of schizophrenia (diagnosed using DSM-IV criteria). A total of 180 patients were randomized equally to the two treatment arms. Patients remained in the hospital until the day 28 assessment after which patients could be discharged or remain hospitalized. The primary efficacy measure was the BPRSd extracted from the PANSS. The secondary efficacy measures included the PANSS total and positive, negative, general psychopathology, and cognitive subscales; the CGI-S, and the MADRS.

About Lurasidone

Lurasidone is a novel compound synthesized and developed by Dainippon Sumitomo Pharma Co., Ltd. (DSP), as a potential psychotropic agent for the treatment of schizophrenia. Lurasidone has a unique chemical structure that differs from conventional and atypical antipsychotic agents. It possesses high affinities for dopamine D(2), serotonin 5-HT(7), 5-HT(2A), 5-HT(1A), and noradrenaline alpha(2C) receptors. Lurasidone exhibits little or no affinity for histamine H(1) or acetylcholine M(1) receptors.

About Schizophrenia

Schizophrenia is a chronic, disabling and serious medical illness that affects between two to three million American adults and more than 24 million adults worldwide. It affects men and women equally and occurs at similar rates in all ethnic groups around the world. Schizophrenia is a treatable medical condition and is thought to be caused by a combination of environmental and genetic factors. The condition is characterized by positive and negative symptoms, such as hallucinations, delusions, disorganized thinking, lack of emotion, lack of energy, as well as cognitive impairments including problems with memory, attention and the ability to plan, organize and make decisions. In 2002, the overall cost of schizophrenia in the United States was estimated to be $62.7 billion, with $22.7 billion in direct health care costs.

About Dainippon Sumitomo Pharma

Dainippon Sumitomo Pharma Co., Ltd., (DSP), is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP's strong research and development presence in the areas of CNS, diabetes, cardiovascular disease, and inflammation/allergy, is based on the merger in 2005 between Sumitomo Pharmaceuticals Co., Ltd., and Dainippon Pharmaceutical Co., Ltd. Today, DSP has about 5,000 employees with operations worldwide. Located in Fort Lee, NJ, Dainippon Sumitomo Pharma America, Inc. is a subsidiary of DSP.

SOURCE Dainippon Sumitomo Pharma Co., Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant
2. Data From Clinical Study of bioTheranostics Molecular Diagnostic Test Presented at American Society of Clinical Oncology Annual Meeting
3. Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
4. Trubion Announces Positive Data From a Phase 1 / 2 Study of TRU-016 for the Treatment of Chronic Lymphocytic Leukemia (CLL)
5. Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients
6. Results and Additional Analyses From Study Show That Cortheras Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables
7. Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
8. Study Showed Lillys GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients
9. Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
10. New Study: Antidepressants Commonly Prescribed with Tamoxifen Put Women at Much Higher Risk for Recurrent Breast Cancer
11. Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology
Post Your Comments:
(Date:11/30/2015)... , Nov. 30, 2015 ... of the "Orphan Drugs Market 2015-2019" ... ) has announced the addition of the ... offering. --> Research and Markets ( ... "Orphan Drugs Market 2015-2019" report to ...
(Date:11/30/2015)... , Nov. 30, 2015   Royal ... announced the launch of Radiology Solutions, a fully ... Radiology Solutions comprises customized, data-driven practice management approaches ... to help radiology practices improve care delivery and ... 2015 Radiological Society of North America Annual Meeting ...
(Date:11/30/2015)... SAN FRANCISCO , Nov. 30, 2015 ... and Designers of Things (DoT ) co-located events ... Printing and the Internet of Things, will draw more ... San Jose Convention Center. The events, combined ... their latest technologies. --> ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... An inventor from Charlottesville, Va., is concerned ... last baby had high blood pressure due to loud noises," she said, "so I ... from noise pollution as well as radio waves and microwaves." , The baby BABY ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... suite of automated breast density assessment and enterprise analytics solutions, here at ... 4, 2015 (South Hall booth #2377). Volpara’s quantitative breast imaging tools enable ...
(Date:11/30/2015)... ... November 30, 2015 , ... Holcomb – ... leading plastic surgery practices in Florida, is proud to announce that Dr. Joshua ... innovations giant Ethicon Inc., a Johnson & Johnson Company. , Ethicon is a ...
(Date:11/30/2015)... ... November 30, 2015 , ... The successful filing of an Investigational ... it is so important to this key industry segment, Regis Technologies has decided to ... on December 4th at 11am EST. , Federal law does not allow new drugs ...
(Date:11/30/2015)... Phoenixville, PA (PRWEB) , ... November 30, 2015 ... ... all of the assets of DataTrade Solutions Inc., a Healthcare IT consulting, development ... by utilizing the programming and technical experience available within DataTrade to extend the ...
Breaking Medicine News(10 mins):