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Lurasidone Demonstrated Efficacy In Treating Patients With Schizophrenia In Pivotal Phase 3 Study

August 27, 2009

Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced positive results from PEARL 2 - a appearance 3 clinical trial of lurasidone toward the treatment of patients with schizophrenia. In this trial, both lurasidone 40 and 120 mg/day were significantly more cogent than placebo in quest of the usage of schizophrenia. Lurasidone was well-tolerated through each overall discontinuation rate that was similar to placebo.

“We are pleased by the results of this study as these data reinforce our belief that lurasidone elect be an prominent treatment option for patients with schizophrenia,” said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. “We plan to submit our NDA filing bale for lurasidone to the U.S. FDA in premature 2010.”

PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) is part of an expanded worldwide phase 3 clinical development program, involving else than 2,000 patients, intended to evaluate the safety and efficacy of lurasidone for the treatment of schizophrenia. The PEARL 2 study was a double-blind, fixed-dose, placebo-controlled clinical experimental knowledge involving 478 inpatients with pointed schizophrenia that were randomized to receive either lurasidone 40 or 120 mg/day, olanzapine 15 mg/day or placebo for six weeks. The active comparator, olanzapine, was used for purposes of establishing assay sensitivity.

Lurasidone 40 and 120 mg, taken once-daily, demonstrated significantly greater improvement against placebo attached the primary efficacy judge of, the Positive and Negative Syndrome Scale (PANSS) total score, at study endpoint. PANSS score changes from baseline for lurasidone 40 and 120 mg/day against placebo were -25.7 and -23.6 vs. -16.0, particularly, at study endpoint. A total of 53% of patients on lurasidone 40 mg/twenty-four hours and 47% of patients on lurasidone 120 mg/day demonstrated a 30% or more amending on the PANSS total score from baseline versus 38% onward placebo.

In addition, both lurasidone dose groups were significantly more efficacious than placebo on the Clinical Global Impressions Severity scale (CGI-S), the key secondary strength endpoint. The CGI-S score changes from baseline for lurasidone 40 and 120 mg/day versus placebo were -1.5 and -1.4 vs. -1.1, respectively, at study endpoint.

“Patients with schizophrenia and their health care providers are in need of new method of treating options that provide consistent efficacy with a lower impact upon the body weight, lipids, and movement disorders,” said Herbert Meltzer, M.D., a study investigator and professor of psychiatry and pharmacology at the Vanderbilt University School of Medicine. “Lurasidone appears to be a potentially significant new treatment selection for schizophrenia.”

The effect of lurasidone on weight was homogeneous to placebo [median gravity change: 0.9 kg (2 lbs) for 40 mg/day, 0.5 kg (1.1lbs) for 120 mg/day vs. 0 kg during placebo at study endpoint]. The incidence of clinically significant heaviness gain (greater than or equal to 7% increase from baseline to examine endpoint) was 7.6% for lurasidone 40 mg/day, 4.2% for lurasidone 120 mg/sunshine and 7.0% in favor of placebo.

Changes in total cholesterol and other lipid measurements as far as concerns both lurasidone doses (40 and 120 mg/day) were uniform to placebo (median change: lump cholesterol -8.0 mg/dL and -5.0 mg/dL vs. -5.0 mg/dL placebo; and triglycerides -3.0 mg/dL and 4.5 mg/dL vs. -1.0 mg/dL placebo, respectively, at subject of attention endpoint).

“PEARL 2 premises are consistent with previous lurasidone placebo-controlled studies and underscore the possible of lurasidone to effectively entertainment patients with schizophrenia,” said Antony Loebel, M.D., evil president of clinical research, Dainippon Sumitomo Pharma America, Inc.

Lurasidone was also well-tolerated with an overall discontinuation rate similar to placebo (40% vs. 39% placebo) and scarcely any adverse event-related discontinuations (9% for both the overall lurasidone group and placebo). Adverse events seen in the sorrow were generally mild. The most commonly reported untoward events for lurasidone 40 and 120 mg/day combined (greater than 5% and at least twice the value of placebo) were akathisia (17.3% vs. 0.9% placebo), somnolency (12.2% vs. 4.3% placebo), sedation (11.4% vs. 3.4% placebo), parkinsonism (10.1% vs. 1.7% placebo), nausea (9.3% vs. 4.3% placebo), and dystonia (5.5% vs. 0.9% placebo).

Olanzapine 15 mg/day produced significantly greater improvements than placebo on the one and the other the PANSS amount score (-28.7 vs. -16.0 placebo) and CGI-S (-1.5 vs. -1.1 placebo). A integral of 64% of patients on olanzapine demonstrated a 30% or more improvement on the PANSS full score from baseline against 38% adhering placebo. Patients on olanzapine reported a 3.1 kg (6.8 lbs) increase in median heaviness gain at study endpoint. The incidence of clinically significant make heavy gain (greater than or equal to 7% increase from baseline to study endpoint) for olanzapine was 34.4% vs. 7.0% placebo. Olanzapine-treated patients had a greater increase in lipid parameters versus placebo (median change: total cholesterol 9.0 mg/dL vs. -5.0 mg/dL placebo; and triglycerides 24.0 mg/dL vs. -1.0 mg/dL placebo at study endpoint). The most commonly reported adverse events for olanzapine (greater than 5% and at least twice the rate of placebo) were increased weight (20.5% vs. 5.2% placebo), sedation (13.9% vs. 3.4% placebo), dry mouth (9.8% vs. 0.9% placebo), sleepiness (9.0% vs. 4.3% placebo) and akathisia (7.4% vs. 0.9% placebo).

The company has submitted the results of the burden in favor of presentation at a scientific confluence at the end of this year.

PEARL 2 Study Overview

This randomized, fixed-dose, placebo-controlled, double-blind, multinational clinical trial was conducted at 52 sites worldwide in the first place in hospital settings. Twenty-five sites in the United States randomized 286 patients, 18 sites in Asia randomized 115 patients, five sites in South America randomized 48 patients and four sites in Europe randomized 29 patients.

Patients were diagnosed by schizophrenia (using DSM-IV criteria) and were required to have every acute exacerbation of psychotic symptoms with a PANSS total score of 80 or higher at study baseline. Trial participants had a sneaking vale of years of 37.7 years with an average PANSS score of 96.6 at baseline. Patients had been diagnosed by schizophrenia, on mean proportion, for more than 13 years and principally had been beforehand hospitalized prior to entering the meditate. Multiple safety assessments were done, including very necessary signs, weight, ECGs, movement disorder scales (SAS, BAS, AIMS), and laboratory assessments.

About Lurasidone

Lurasidone is an atypical antipsychotic discovered and developed by DSP through a unique chemical structure. Lurasidone has high affinities for dopamine D2, serotonin 5-HT7, 5-HT2A, 5-HT1A, and noradrenalin alpha2C receptors and minimal-to-no affinity for histamine H1 or cholinergic M1 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. Schizophrenia affects men and women equally and occurs at similar rates in aggregate ethnic groups around the world. Schizophrenia is a treatable medical condition and is fancy to be caused by a combination of environmental and genetic factors. The class is characterized by positive and negative symptoms, such as hallucinations, delusions, disorganized thinking, lack of mental agitation, lack of spiritedness, as well as cognitive impairments including problems by memory, attention and the quickness to plan, organize and occasion decisions. In 2002, the overall require to be paid of schizophrenia in the United States was estimated to be $62.7 billion, through $22.7 billion in direct health care costs.

About Dainippon Sumitomo Pharma

Dainippon Sumitomo Pharma Co., Ltd., (DSP), is a top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and pabulum and specialty products. DSP’s strong research and development carriage in the areas of CNS, diabetes, cardiovascular disease, and inflammation/allergy, is based on the merger in 2005 betwixt Sumitomo Pharmaceuticals Co., Ltd., and Dainippon Pharmaceutical Co., Ltd. With global expansion plans on the horizon, this multi-billion dollar company has about 5,000 employees worldwide. Through its exploration and expanse efforts, DSP aims to offer its experience, commitment and vision worldwide. Located in Fort Lee, NJ, Dainippon Sumitomo Pharma America, Inc. is a subsidiary of DSP.

Source: Dainippon Sumitomo Pharma

Written by Samanta · Filed Under Pharmacy Industry News