FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Sch... (efficacy by counts of 12/0/0 and 9/1/2 f...)

FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

Date:7/30/2009

efficacy by counts of 12/0/0 and 9/1/2 for the bipolar I disorder and schizophrenia indications, respectively.

The New Drug Application (NDA) for SAPHRIS includes efficacy data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials, and is supported by safety data in 4,500 patients, with some treated for more than two years.

In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST(R), is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.

About Schizophrenia

Schizophrenia is a chronic, disabling brain disorder that is characterized by hallucinations, delusions and disordered thinking. The condition affects about 24 million people worldwide (or seven in every 1,000 adults in the population), including more than two million people in the United States and more than four million people in Europe. Although there are a number of medications available for patients, treatment success for any antipsychotic agent can be unpredictable because patients often respond differently to various medications. Among patients with schizophrenia who are being treated with antipsychotics, nearly three in four patients discontinue therapy within 18 months due to either poor tolerability or incomplete efficacy. Metabolic safety, including weight gain, elevation of lipid levels (dyslipidemia) and glucose dysregulation, is an important consideration with any antipsychotic treatment. Patients often need to switch treatments in order for physicians to balance effective treatment with the long-term safety of their pati
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