Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the US Food and Drug Administration (FDA) has approved the Supplemental New Drug Applications (sNDAs) for the use of Risperdal Consta (risperidone) long-acting treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder.
Risperdal® Consta® is the first and only long-acting antipsychotic therapy available for bipolar I disorder.
“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, MD, 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, randomised, double-blind, placebo-controlled studies for the long-term treatment of bipolar I disorder. The first demonstrated that Risperdal Consta, 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 Consta significantly delayed the time to relapse compared with current treatments plus placebo.
“We are very pleased with this FDA approval for Risperdal Consta,” said Husseini Manji, MD, 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.”