FDA OKs New Schizophrenia, Bipolar Drug
Saphris Trumps Placebo at Reducing Symptoms of Schizophrenia, Bipolar Disorder
WebMD News Archive
Aug. 14, 2009 -- The FDA has approved a new drug called Saphris to treat
schizophrenia and bipolar I disorder in adults.
"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
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
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
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
Saphris is made by the drug company Schering-Plough.