(dailyRx News) The FDA has approved the Supplemental New Drug Applications (sNDAs) for using Risperdal Consta (risperidone) alone and in combination with lithium or valproate to treat bipolar disorder.
Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression). Type 1 bipolar disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode; it affects approximately 1 percent of the adult population of the U.S. in any given year.
"Long-acting therapies are moving to the forefront of treatment for mental illness, and the approval of risperidone long-acting treatment for bipolar disorder is exciting because it offers physicians assurance that the medication is being taken as prescribed," said Caleb Adler, M.D., principal investigator and associate professor of Clinical Psychiatry at the University of Cincinnati. "Further, the biweekly administration schedule encourages regular contact between patients and their treatment team."
The approval is based on two prospective, randomized, double-blind, placebo-controlled studies for the long-term treatment of bipolar disorder. The first demonstrated that Risperdal Consta, when used alone, was significantly better than placebo at delaying the time to relapse of any mood episode. The second study demonstrated that for patients already taking lithium or valproate, the addition of Risperdal Consta significantly delayed the time to relapse compared to current treatments plus placebo.
Risperdal Consta was approved in 2003 as an atypical antipsychotic agent for schizophrenia. It is now the first and only long-acting injectable antipsychotic therapy available for the treatment of schizophrenia and bipolar disorder.
Full prescribing information is available at www.risperdalconsta.com.