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 acutetreatment of manic or mixed episodes associated with bipolar I disorder withor without psychotic features in adults. SAPHRIS can be used as a first-linetreatment and is the first psychotropic drug to receive initial approval forboth of these indications simultaneously.
SAPHRIS is expected to be available in the U.S. during the fourth quarterof 2009.
Schizophrenia affects about 24 million people worldwide, including twomillion 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
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Important Safety Information about SAPHRIS
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. Analyses of 17placebo-controlled trials (modal duration of 10 weeks), largely in patientstaking atypical antipsychotic drugs, revealed a risk of death in thedrug-treated patients of between 1.6 to 1.7 times that seen inplacebo-treated patients. Over the course of a typical 10-week controlledtrial, the rate of death in drug-treated patients was about 4.5 percentcompared to a rate of 2.6 percent in the placebo group. Although the causesof death were varied, most of the deaths appeared to be either cardiovascular(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) innature. SAPHRIS is not approved for the treatment of patients withdementia-related psychosis.
Cerebrovascular Adverse Events: There was a higher incidence ofcerebrovascular adverse reactions (cerebrovascular accidents and transientischemic attacks) including fatalities compared to placebo-treated subjects.SAPHRIS is not approved for the treatment of patients with dementia-relatedpsychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptomcomplex, has been reported with administration of antipsychotic drugs,including SAPHRIS. NMS can cause hyperpyrexia, muscle rigidity, alteredmental status, irregular pulse or blood pressure, tachycardia, diaphoresisand cardiac dysrhythmia. Additional signs may include elevated creatinephosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.Management should include immediate discontinuation of antipsychotic drugsand other drugs not essential to concurrent therapy, intensive symptomatictreatment and medical monitoring, and treatment of any concomitant seriousmedical problems.
Tardive Dyskinesia (TD): The risk of developing TD and the potential forit to become irreversible may increase as the duration of treatment and thetotal cumulative dose increase. However, the syndrome can develop, althoughmuch less commonly, after relatively brief treatment periods at low doses.Prescribing should be consistent with the need to minimize TD. If signs andsymptoms appear, discontinuation should be considered.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some casesassociated with ketoacidosis, hyperosmolar coma or death, has been reportedin patients treated with atypical antipsychotics. Patients with risk factorsfor diabetes mellitus who are starting treatment with atypical antipsychoticsshould undergo fasting blood glucose testing at the beginning of and duringtreatment. Any patient treated with atypical antipsychotics should bemonitored for symptoms of hyperglycemia including polydipsia, polyuria,polyphagia and weakness. Patients who develop symptoms of hyperglycemiaduring treatment with atypical antipsychotics should also undergo fastingblood glucose testing. In some cases, hyperglycemia has resolved when theatypical antipsychotic was discontinued; however, some patients requiredcontinuation of anti-diabetic treatment despite discontinuation of theantipsychotic drug.
Weight Gain: In short-term schizophrenia and bipolar mania trials, therewere differences in mean weight gain between SAPHRIS-treated andplacebo-treated patients. In a 52 week study, the proportion of patients withan equal to or greater than 7 percent increase in body weight was 14.7percent.
Orthostatic Hypotension and Syncope and Other Hemodynamic Effects:SAPHRIS may induce orthostatic hypotension and syncope. SAPHRIS should beused with caution in patients with known cardiovascular disease,cerebrovascular disease, conditions which would predispose them tohypotension and in the elderly. SAPHRIS should be used cautiously whentreating patients who receive treatment with other drugs that can inducehypotension, bradycardia, respiratory or central nervous system depression.Monitoring of orthostatic vital signs should be considered in all suchpatients, and a dose reduction should be considered if hypotension occurs.
Leukopenia, Neutropenia, and Agranulocytosis: In clinical trial andpostmarketing experience, events of leukopenia/neutropenia have been reportedtemporally related to antipsychotic agents, including SAPHRIS. Patients witha pre-existing low white blood cell count (WBC) or a history ofleukopenia/neutropenia should have their complete blood count (CBC) monitoredfrequently during the first few months of therapy and SAPHRIS should bediscontinued at the first sign of a decline in WBC in the absence of othercausative factors.
QT Prolongation: SAPHRIS was associated with increases in QTc intervalranging from 2 to 5 msec compared to placebo. No patients treated withSAPHRIS experienced QTc increases of equal to or greater than 60 msec frombaseline measurements, nor did any experience a QTc of equal to or greaterthan 500 msec. SAPHRIS should be avoided in combination with other drugsknown to prolong QTc interval, in patients with congenital prolongation of QTinterval or a history of cardiac arrhythmias, and in circumstances that mayincrease the occurrence of torsades de pointes and/or sudden death inassociation with the use of drugs that prolong the QTc interval.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2receptors, SAPHRIS can elevate prolactin levels, and the elevation canpersist during chronic administration. Galactorrhea, amenorrhea, gynecomastiaand impotence have been reported in patients receiving prolactin-elevatingcompounds.
Seizures: SAPHRIS should be used cautiously in patients with a history ofseizures or with conditions that lower seizure threshold, e.g., Alzheimer'sdementia.
Dysphagia: Esophageal dysmotility and aspiration have been associatedwith antipsychotic drug use. Aspiration pneumonia is a common cause ofmorbidity and mortality in elderly patients, in particular those withadvanced Alzheimer's dementia. SAPHRIS is not indicated for the treatment ofdementia-related psychosis, and should not be used in patients at risk foraspiration pneumonia.
Potential for Cognitive and Motor Impairment: Somnolence was reported inpatients treated with SAPHRIS. Patients should be cautioned about performingactivities requiring mental alertness, such as operating hazardous machineryor operating a motor vehicle, until they are reasonably certain that SAPHRIStherapy does not affect them adversely.
Suicide: The possibility of suicide attempt is inherent in psychoticillnesses and bipolar disorder. Close supervision of high-risk patientsshould accompany drug therapy. Prescriptions for SAPHRIS should be writtenfor 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 5percent and at least twice that for placebo) were: Patients withSchizophrenia: akathisia, oral hypoesthesia and somnolence. Patients withBipolar Disorder: somnolence, dizziness, extrapyramidal symptoms other thanakathisia and weight increase.
NEWS: SAPHRIS (asenapine), a new psychotropic agent, represents animportant new choice for acute treatment of schizophrenia and acute manic ormixed episodes of bipolar I disorder with or without psychotic features inadults.
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