"Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy," Thomas Laughren, MD, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, says in a news release.
"Effective medicines can help people with mental illness live more independent lives," Laughren says.
The FDA notes that 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.
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, fast talking, impulsive behavior, and a decreased need for sleep.
Saphris, which comes in tablets, belongs to a class of drugs called atypical antipsychotics.
The FDA approved Saphris based on clinical trials in which the drug trumped a placebo at reducing schizophrenia symptoms in adults and other trials in which Saphris was better than a placebo at treating symptoms of bipolar disorder.
In clinical trials, the most common side effects reported by schizophrenia patients being treated with Saphris were the inability to sit still or remain motionless, decreased oral sensitivity, and drowsiness.
The most common side effects in clinical trials of patients treated with Saphris for bipolar disorder were drowsiness, dizziness, movement disorders other than the inability to sit still or remain motionless, and weight gain.
All atypical antipsychotic drugs carry a "black box" warning, the FDA's sternest warning, alerting prescribers about 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 isn't approved for those patients.
Saphris is made by the drug company Schering-Plough.