The Food and Drug Administration (FDA) today approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia. Paliperidone is a new molecular entity, which means this medication contains an active substance that has never before been approved for marketing in any form in the United States. Paliperidone is the principal active metabolite of risperidone, a marketed drug for treating schizophrenia.
“Schizophrenia can be a devastating illness requiring lifelong medication and professional counseling,” said Douglas Throckmorton, MD, Deputy Director of FDA’s Center for Drug Evaluation and Research. “Today’s approval adds to the treatment options for patients with this condition.”
Schizophrenia is a chronic, disabling mental disorder that affects more than two million Americans. Symptoms include hallucinations, delusions, disordered thinking, movement disorders, social withdrawal and cognitive deficits (e.g., difficulty with perception, memory or abstract thinking that interferes with one’s ability to learn; impaired judgment, inattentiveness, impulsiveness or impairment of speech and language).
The effectiveness of Invega in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled trials conducted in North America, Europe and Asia. The 1665 participating adults were evaluated for the full array of signs and symptoms of schizophrenia. In the three studies using doses ranging from three milligrams (mg) to 15 mg a day, the effectiveness of Invega at relieving symptoms of schizophrenia was superior to the placebo treatment. The recommended dose range for Invega is three mg to 12 mg a day.
Among the commonly reported adverse events were restlessness, extrapyramidal symptoms (movement disorders), rapid heart beat and sleepiness. Invega is a member of a class of drugs called atypical antipsychotics that have an increased rate of death compared with placebo in elderly patients with dementia-related psychosis. Invega is not approved for dementia-related psychosis.
The effectiveness of Invega has not been evaluated in placebo-controlled trials for longer than six weeks, and patients who use the drug for extended periods should be periodically reevaluated by a physician.
Invega is manufactured by ALZA Corp. in Mountain View, CA. for Janssen, L.P. in Titusville, NJ.
From U.S. FDA