Risperdal Consta is a long-acting injection used as both a monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder.
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 this drug, 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 to current treatments plus placebo.
However, Risperdal Consta is not approved for the treatment of patients with dementia-related psychosis. If the person is being treated has Neuroleptic Malignant Syndrome (NMS), the treatment should be stopped as this could have a fatal side effect.
This same drug was approved in 2003 as an atypical antipsychotic agent indicated for the treatment of schizophrenia and is now the first and only long-acting atypical antipsychotic therapy available for the treatment of schizophrenia and bipolar I disorder.
Risperdal Consta is manufactured by Alkermes, and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals in the US, and Janssen-Cilag outside of the US.
Elliot Ehrich, Chief Medical Officer of Alkermes, said: “We believe that the strong clinical data demonstrating safety and efficacy to treat this disorder, as well as years of clinical experience with Risperdal Consta in the prescribing community will make this a valuable treatment for managing this serious, chronic disease.”
