FDA OKs New Schizophrenia Drug
The FDA has approved a new antipsychotic drug, called Invega Extended-Release Tablets, to treat schizophrenia.
Dec. 20, 2006 -- The FDA today approved a new antipsychotic drug, called
Invega Extended-Release Tablets, to treat schizophrenia. The
new drug -- a pill to be taken once a day -- will be available in the U.S. in
January. The recommended dose range is 3-12 milligrams daily.
Invega is the first new prescription treatment for schizophrenia approved by
the FDA since 2003, according to Janssen, the mental healthdrug
company that markets Invega. Janssen is part of Johnson & Johnson, a WebMD
The drug's key ingredient, paliperidone, is a new chemical. It is derived
from another schizophrenia drug, Risperdal, which is also marketed by
More than 2 million Americans have schizophrenia, a chronic, disabling
Its symptoms include hallucinations, delusions, disordered thinking,
movement disorders, social withdrawal, and mental deficits. Possible problems
include difficulty with perception, memory, or abstract thinking that
interferes with one's ability to learn; impaired judgment; inattentiveness;
impulsiveness; and impairment of speech and language.
"Schizophrenia can be a devastating illness requiring lifelong
medication and professional counseling," says Douglas Throckmorton, MD,
deputy director of the FDA's Center for Drug Evaluation and Research.
"Today's approval adds to the treatment options for patients with this
condition," he says in an FDA news release.
Tested in 1,700 Patients
Invega's effectiveness was established in three trials that included 1,665
schizophrenia patients in North America, Europe, and Asia.
They took either Invega or a sham medicine (placebo) for six weeks.
Invega was more effective than the placebo at treating schizophrenia, says
Restlessness, movement disorders, rapid heart beat, and sleepiness were
among the commonly reported adverse events in Invega trials.
Invega is part of a class of drugs, called atypical antipsychotics,
connected to an increased death rate in elderly patients with dementiadementia-related psychosis. Invega is not approved
for that condition.
Invega's effectiveness has not been evaluated in clinical trials lasting
longer than six weeks.
Patients who use Invega for extended periods should be periodically
re-evaluated by a doctor, advises the FDA.