The FDA ( Food and Drug Administration ) has approved Saphris tablets ( Asenapine ) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function.

The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs ( for example, believing that others are controlling thoughts, reading minds, or plotting harm ), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.

Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

Saphris is an atypical antipsychotics. All atypical antipsychotics contain a boxed warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. Saphris is not approved for these patients.

The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to placebo in reducing the symptoms of schizophrenia.

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless ( akathisia ), decreased oral sensitivity ( oral hypoesthesia ) and somnolence.

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.

Source: FDA, 2008

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