Dainippon Sumitomo Pharma America Announces The NDA Submission Of Lurasidone To The FDA For The Treatment Of Schizophrenia
Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2, 500 lurasidone-treated patients. "This NDA marks a significant milestone for our company as we accelerated the global clinical development of lurasidone and achieved an earlier than anticipated submission to the FDA, " said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co.
EnVivo Pharmaceuticals announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe. The study is designed to determine the safety and efficacy of EVP-6124 in producing procognitive effects and improving executive function in schizophrenic patients who typically exhibit significant cognitive symptoms that impair normal functioning. This study will determine if EVP-6124 can produce both cognitive and clinical improvement in schizophrenic patients.
Scientists have long eyed mutations in a gene known as DISC1 as a possible contributor to schizophrenia and mood disorders, including depression and bipolar disorder. Now, new research led by Johns Hopkins researchers suggests that perturbing this gene during prenatal periods, postnatal periods or both may have different effects in mice, leading to separate types of brain alterations and behaviors with resemblance to schizophrenia or mood disorders. The findings, reported online Jan. 5 in Molecular Psychiatry, could eventually help researchers treat mental illness in people or even prevent it. To manipulate DISC1 expression during different periods, the researchers, led by Associate Professor Mikhail Pletnikov, M.
Scientists have resolved a question about how a popular class of drugs used to treat schizophrenia works using biosensors that reveal previously hidden components of chemical communication in the brain. Although delusions and hallucinations characterize the illness, people with schizophrenia also struggle to sustain attention or recall information in a particular order, difficulties that interfere with their ability to hold a job or function well, said Lee Schroeder, a student in the medical scientist training program at the University of California, San Diego. A class of drugs called atypical neuroleptics has become the most commonly prescribed treatment for schizophrenia, in part for their ability to improve these cognitive functions.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The IND for Staccato loxapine was filed with the FDA in August 2005. "AZ-004 has delivered a predictable and consistent safety and efficacy profile in treating patients with agitation, " said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza. "We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients' desire for quickly and comfortably gaining control, and the clinicians' goal of rapidly and reliably calming an agitated patient.
Intra-Cellular Therapies Announces The Results Of A Phase I PET Study For ITI-007 For The Treatment Of Schizophrenia And Other Psychiatric Disorders
Intra-Cellular Therapies, Inc. (ITI) announced at a recent conference on neuropsychiatric diseases the results from a recently completed Phase I clinical study demonstrating ITI-007, the Company's lead antipsychotic drug, interacts with important targets in the living human brain. These key targets are critical to drug action in many neuropsychiatric and related disorders. Using positron emission tomography (PET) to image receptor interactions, ITI-007 produced dose-related and long-lasting occupancy of three key targets of psychotropic drug action: the serotonin 5-HT2A and dopamine D2 receptors, as well as the serotonin reuptake transporter (SERT).