Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Applications (sNDAs) for the use of RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder (see also 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 I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately 1 percent of the American adult population 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 bi-weekly 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 I Disorder. The first demonstrated that RISPERDAL(R) CONSTA(R), when used as a monotherapy, 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(R) CONSTA(R) significantly delayed the time to relapse compared to current treatments plus placebo.
"We are very pleased with this FDA approval for RISPERDAL(R) CONSTA(R)," said Husseini Manji, M.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research and Development. "We are committed to creating new, long-acting therapies that offer safe and effective products for treating patients with mental illnesses. This approval provides physicians and patients with a new treatment option that offers a convenient and effective choice to delay relapse."
RISPERDAL(R) CONSTA(R) was approved in 2003 as an atypical antipsychotic agent indicated for the treatment of schizophrenia and is now the first and only long-acting injectable antipsychotic therapy available for the treatment of schizophrenia and Bipolar I Disorder.
Visit http://www.risperdalconsta.com/ for full prescribing information.
About RISPERDAL(R) CONSTA(R)
Risperidone long-acting treatment (RLAT) is a long-acting injectable form of risperidone that was developed utilizing Alkermes' proprietary Medisorb(R) drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. RLAT is manufactured by Alkermes, Inc. and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag outside of the U.S.
