FDA Advisory Committee Votes In Favor Of SAPHRIS R asenapine For Acute Bipolar I Disorder And Acute Schizophrenia
Schering-Plough Corporation (NYSE: SGP) announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute treatment of schizophrenia in adults. If approved by FDA, SAPHRIS would be the first psychotropic drug to be approved initially for both of these indications. "We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the efficacy and safety data for SAPHRIS, " said Thomas P.
SAPHRIS R asenapine Meets Primary Endpoint In Long-Term Extension Study In Patients With Predominant, Persistent Negative Symptoms Of Schizophrenia
Schering-Plough Corporation (NYSE: SGP) announced that its investigational agent SAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment in an extension study in patients with predominant, persistent negative symptoms of schizophrenia. Negative symptoms of schizophrenia include apathy, lack of emotion and poor social functioning, among others. In the study, these symptoms were assessed using the validated 16-item Negative Symptom Assessment scale (NSA-16). "These symptoms are among the most difficult to treat in the schizophrenia spectrum, " said Armin Szegedi, M.D., Ph.D., vice president, global clinical research, central nervous system, Schering-Plough Research Institute.
Schizophrenia is a severely debilitating psychiatric disease that is thought to have its roots in the development of the nervous system; however, major breakthroughs linking its genetics to diagnosis, prognosis and treatment are still unrealized. Jill Morris, PhD assistant professor of Pediatrics at Northwestern University's Feinberg School of Medicine and a researcher in the Human Molecular Genetics Program of Children's Memorial Research Center studies a gene that is involved in susceptibility to schizophrenia, Disc1 (Disrupted-In-Schizophrenia 1). Two recent publications by Morris and colleagues focus on the role of Disc1 in development, particularly the migration of cells to their proper location in the brain and subsequent differentiation into their intended fate.
Abilify Has Made Strong Gains In Patient Share Across All Lines Of Therapy Since Last Year's Analysis Of Prescribing Trends In Schizophrenia
Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that the patient share of Bristol-Myers Squibb/Otsuka's Abilify has grown in the first three lines of therapy since the 2008 analysis of prescribing trends in newly diagnosed schizophrenia patients. Abilify is second to risperidone (Janssen's Risperdal, generics) in first and second lines of therapy and leads other atypicals in the third line. "Abilify's first-line patient share grew from 4.2 percent in our 2008 analysis to 14.6 percent in the current dataset. Pfizer's ziprasidone mesylate). External link" target="_blank">Geodon also grew substantially compared with our 2008 analysis whereas both Eli Lilly's Zyprexa and AstraZeneca's Seroquel lost first-line patient share, " stated Nicole Westphal, Ph.
Columbia University Medical Center's Jeffrey A. Lieberman, M.D., a renowned expert in the field of schizophrenia, has been selected by the National Institute of Mental Health (NIMH) of the National Institutes of Health as principal investigator of a nationwide effort to develop an optimal early intervention strategy for treating people experiencing a first episode of the psychotic symptoms of schizophrenia. Research has shown that early treatment can alter the course of schizophrenia and related psychotic disorders by dramatically slowing progression; reducing disability, mortality, and the expense of care; and increasing recovery. The Recovery After Initial Schizophrenic Episode (RAISE) study, funded at $9.
22nd Congress of the European College of Neuropsychopharmacology (ECNP), 12 - 16 September 2009, Istanbul, Turkey Professor William T. Carpenter from the Maryland Psychiatric Research Center, University of Maryland School of Medicine, USA, will present the major directions of current scientific activities and point to the clinical implications of this paradigm shift, which is influencing virtually all aspects of schizophrenia research. He will explain that impaired cognition and negative symptoms represent attractive indications for drug development, raising the possibility of very early intervention and secondary prevention. Schizophrenia is a major public health problem: Affecting almost 1% of the world's population, it takes an enormous economic and social toll in addition to the distress, dysfunction, disability and mortality for those afflicted with this disease.