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Asenapine in Medical News

Study Shows Organon's Asenapine Demonstrates Efficacy and Tolerability in Treating Acute Schizophrenia

OSS, Netherlands, Nov. 14 /PRNewswire/ -- Asenapine -- a fast- dissolving, sublingual tablet being developed by Organon -- was shown to be effective and well-tolerated in patients with acute schizophrenia, according to a six-week study published in the current issue of the Journal of Clinical ...

Schering-Plough Announces European Filing of SYCREST(R) (asenapine) for the Treatment of Schizophrenia and Bipolar I Disorder

.... The MAA for SYCREST includes data from the asenapine clinical trial program involving more than 3,000 p...nia and bipolar mania trials. "We highlighted asenapine as one of the Five Stars in our late-stage researc...ime, we said that our aspirational filing date for asenapine in Europe was in 2009," noted Thomas P. Koestler, ...
Asenapine in Medical Technology

Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting

Efficacy and safety data support potential of asenapine in the treatment of schizophrenia and bipolar I disorder WASHINGTON, May 8 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that an overview of asenapine clinical trials from the Olympia p...

New Study Results Show Asenapine More Effective Than Placebo in the Treatment of Acute Schizophrenia

KENILWORTH, N.J., Dec. 17 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported on new study results that demonstrated that Asenapine, a fast-dissolving, sublingual tablet being developed for treatment of schizophrenia, was more effective than placebo and well tole...

Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA

KENILWORTH, N.J., Nov. 26 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet. Schering-...

Organon's Asenapine Effective in a Phase III Study for the Treatment of Bipolar I Disorder; Results Unveiled at 2007 APA Meeting

SAN DIEGO, May 21, 2007 /PRNewswire/ -- Asenapine -- an investigational drug being developed by Organon, the human healthcare business unit of Akzo Nobel, for bipolar I disorder and schizophrenia -- was demonstrated to be more effective than placebo in treating acute manic and mixed episodes assoc...

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

...phrenia 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 ...

U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

... a request for supplemental data from the existing asenapine database. No additional clinical trials have been...eeded in this therapeutic area and we believe that asenapine has the potential to be an important option in addressing this need." Schering-Plough acquired asenapine in November 2007 through its acquisition of Organo...

Schering-Plough Highlights R&D Pipeline Progress, Innovation and Breadth of Research Projects

... mixed episodes associated with bipolar I disorder); pivotal relapse-prevention data were presented showing that only 12 percent of patients receiving asenapine relapsed at the specified endpoint versus 47 percent of patients receiving placebo; BRIDION(R) (sugammadex), the first and only selective rel...

Schering-Plough Unveils Top-Line Study Results for SAPHRIS(TM) (asenapine) Demonstrating Efficacy in Long-Term Schizophrenia Relapse Prevention

...eventing relapse of schizophrenia. In this trial, asenapine was statistically significantly more effective tha... of the asenapine-treated patients (p<0.0001). asenapine was generally well tolerated, with somnolence and ...p-line data we are sharing today. We believe that asenapine may have the potential to help relieve the burden ...
Asenapine in Biological Technology

Organon's Asenapine Further Demonstrates Efficacy in Reducing Mania Symptoms for the Treatment of Bipolar I Disorder

New Data From a Separate Study Also Show Minimal Effect on Heart Rhythm Changes in Schizophrenia Patients VIENNA, Austria, Oct. 17 /PRNewswire/ -- New data show that asenapine -- a psychopharmacologic agent being developed by Organon -- is effective in treating acute manic ep...

SAPHRIS(R) (asenapine) Meets Primary Endpoint in Long-Term Extension Study in Patients With Predominant, Persistent Negative Symptoms of Schizophrenia

...g the same study design and protocol in which both asenapine and olanzapine reduced negative symptoms after one...istically significant treatment effect in favor of asenapine after one year of treatment. These large ... den Hollander W, et al. Long-Term Treatment with asenapine versus Olanzapine in Subjects with Predominant, Pe...

Schering-Plough Reports Financial Results for 2009 Second Quarter

...irst once-monthly subcutaneous treatment; Acceptance for review by the European Medicines Agency (EMEA) in June of the marketing application for asenapine (to be marketed as SYCREST in Europe) sublingual tablets for schizophrenia and bipolar I disorder; Initiation of patient enrollment in a Phase I...

Schering-Plough Submits Response to FDA for SAPHRIS(TM) (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

... a request for supplemental data from the existing asenapine database. No additional clinical trials were requ...esearch Institute. Schering-Plough acquired asenapine in November 2007 through its acquisition of Organo...ychotic agent. The New Drug Application (NDA) for asenapine includes data from a clinical trial program involv...

Asenapine Meets Primary Endpoint in Long-Term Schizophrenia Relapse Prevention Trial

...announced that its novel psychopharmacologic agent asenapine has met the primary endpoint in a long-term schizo...e efficacy and safety of sublingually administered asenapine (5 or 10 mg BID) compared to placebo in the preven...700 subjects entered the open-label treatment with asenapine for up to 26 weeks. Of these, a total of 386 subje...

Schering-Plough Reports Financial Results for 2007 Fourth Quarter, Full Year

... important new agents and indications, which now include sugammadex and asenapine from Organon. "Schering-Plough now has four full years of accomplishments... Nov. 19, 2007) -- Reported on new study results that demonstrated that asenapine was more effective than placebo and well tolerated in treating patients...

Schering-Plough Completes Acquisition of Organon BioSciences

...eline. Schering-Plough's key Phase III projects include (in alphabetical order): * Acadesine, for the prevention of ischemia-reperfusion injury; * asenapine (from Organon), a fast-dissolving, sublingual psychopharmacologic agent for the treatment of patients with schizophrenia and acute mania bipol...
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