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 sponsor.
More than 2 million Americans have schizophrenia, a chronic, disabling mental disorder.
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 the FDA.
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.