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SCHERING-PLOUGH

(SGP)
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SCHERING-PLOUGH : ANNOUNCES FDA APPROVAL OF SAPHRIS(R) (asenapine): for acute treatment of schizophrenia in adults and manic or mixed episodes of bipolar I disorder with or without psychotic features in adults

08/14/2009 | 08:35am EST

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved SAPHRIS(R) (asenapine) sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. SAPHRIS can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously.

SAPHRIS is expected to be available in the U.S. during the fourth quarter of 2009.

Schizophrenia affects about 24 million people worldwide, including two million Americans, and bipolar I disorder affects about 1 percent of adults, including 10 million Americans.

Full prescribing information will be available at www.SAPHRIS.com

For more information about Schering-Plough, please log onto www.schering-plough.com.

Important Safety Information about SAPHRIS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5 percent compared to a rate of 2.6 percent in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. SAPHRIS is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular Adverse Events: There was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. SAPHRIS is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including SAPHRIS. NMS can cause hyperpyrexia, muscle rigidity, altered mental status, irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): The risk of developing TD and the potential for it to become irreversible may increase as the duration of treatment and the total cumulative dose increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with the need to minimize TD. If signs and symptoms appear, discontinuation should be considered.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the antipsychotic drug.

Weight Gain: In short-term schizophrenia and bipolar mania trials, there were differences in mean weight gain between SAPHRIS-treated and placebo-treated patients. In a 52 week study, the proportion of patients with an equal to or greater than 7 percent increase in body weight was 14.7 percent.

Orthostatic Hypotension and Syncope and Other Hemodynamic Effects: SAPHRIS may induce orthostatic hypotension and syncope. SAPHRIS should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, conditions which would predispose them to hypotension and in the elderly. SAPHRIS should be used cautiously when treating patients who receive treatment with other drugs that can induce hypotension, bradycardia, respiratory or central nervous system depression. Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should be considered if hypotension occurs.

Leukopenia, Neutropenia, and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including SAPHRIS. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and SAPHRIS should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.

QT Prolongation: SAPHRIS was associated with increases in QTc interval ranging from 2 to 5 msec compared to placebo. No patients treated with SAPHRIS experienced QTc increases of equal to or greater than 60 msec from baseline measurements, nor did any experience a QTc of equal to or greater than 500 msec. SAPHRIS should be avoided in combination with other drugs known to prolong QTc interval, in patients with congenital prolongation of QT interval or a history of cardiac arrhythmias, and in circumstances that may increase the occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.

Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, SAPHRIS can elevate prolactin levels, and the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia and impotence have been reported in patients receiving prolactin-elevating compounds.

Seizures: SAPHRIS should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold, e.g., Alzheimer's dementia.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. SAPHRIS is not indicated for the treatment of dementia-related psychosis, and should not be used in patients at risk for aspiration pneumonia.

Potential for Cognitive and Motor Impairment: Somnolence was reported in patients treated with SAPHRIS. Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that SAPHRIS therapy does not affect them adversely.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses and bipolar disorder. Close supervision of high-risk patients should accompany drug therapy. Prescriptions for SAPHRIS should be written for the smallest quantity of tablets in order to reduce the risk of overdose.

SAPHRIS is not recommended in patients with severe hepatic impairment.

Co-administration of SAPHRIS with strong CYP1A2 inhibitors (fluvoxamine) or compounds which are both CYP2D6 substrates and inhibitors (paroxetine) should be done with caution.

Commonly observed adverse reactions (incidence equal to or greater than 5 percent and at least twice that for placebo) were: Patients with Schizophrenia: akathisia, oral hypoesthesia and somnolence. Patients with Bipolar Disorder: somnolence, dizziness, extrapyramidal symptoms other than akathisia and weight increase.

    Please see full prescribing information at www.SAPHRIS.com.

    SATELLITE FEEDS:
    Friday, August 14th, 2009          Friday, August 14th, 2009
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NEWS: SAPHRIS (asenapine), a new psychotropic agent, represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder with or without psychotic features in adults.

FORMAT: B-roll and Soundbites

ADDITIONAL RESOURCES: Video, contact information and more available at: http://www.prnewswire.com/broadcast/39460/press.html


    SOUNDBITES:
    * Steven Potkin, MD, Professor, Department of Psychiatry and Human
      Behavior, University of California, Irvine
    * Roger McIntyre, MD, Associate Professor of Psychiatry and Pharmacology,
      University of Toronto, Canada
    * Thomas Koestler, PhD, Executive Vice President and President,
      Schering-Plough Research Institute
    * Herbert Meltzer, MD, Bixler/May/Johnson Professor of Psychiatry and
      Professor of Pharmacology, Department of Psychiatry, Vanderbilt
      University Medical Center

    B-ROLL INCLUDES:
    * Exterior shots of Schering-Plough
    * B-Roll of Dr. Thomas Koestler
    * B-Roll of Dr. Roger McIntyre
    * B-Roll of Dr. Steven Potkin
    * B-Roll of Dr. Herbert Meltzer

VIDEO PROVIDED BY: Schering-Plough

Contact: FOR MORE INFORMATION, PLEASE CALL: MultiVu Media Relations, 1-800-653-5313 EXT. 3

SOURCE Schering-Plough


ę PRNewswire 2009
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