Risperdal Consta (risperidone), a drug already approved in the treatment of schizophrenia, has received approval by the U.S. Food and Drug Administration (FDA) for the treatment of bipolar I disorder. Bipolar I is the most serious form of bipolar disorder, and includes the occurrence of at least one full manic episode.
Risperdal Consta is the long-acting version of Risperdal, which first gained FDA approval in 2003 for the treatment of schizophrenia. Risperdal Consta and Risperdal are manufactured by Janssen Pharmaceuticals.
Risperdal Consta is considered a long-acting therapy, because it only needs to be administered once every two weeks. It is administered as an intramuscular injection by a healthcare professional.
Risperdal (risperidone) is used for the treatment of irritability associated with autistic disorder; the treatment of schizophrenia; and the treatment of acute manic or mixed episodes associated with bipolar I disorder. Risperdal Consta is only approved in the treatment of schizophrenia, and now bipolar I disorder.
Risperdal Consta was approved on its own (“monotherapy”), or in combination with lithium or valproate (called “adjunctive therapy”) in the maintenance treatment of bipolar I disorder.
“We are very pleased with this FDA approval for Risperdal Consta” 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.”
As with similar atypical antipsychotic drugs, Risperdal Consta includes an FDA-mandated warning that the drug is not approved for elderly people with dementia-related psychosis, because of an increased risk of death.
Atypical antipsychotics like Risperdal have been associated with tardive dyskinesia (TD) and increased blood sugar and diabetes.
Tardive dyskinesia (TD) is a serious, sometimes permanent side effect that includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with Risperdal Consta. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
The approval was based on two prospective, randomized, double-blind, placebo-controlled studies for the long-term treatment of Bipolar I Disorder, according to the Janssen news release.
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 to current treatments plus placebo.
Source: Janssen Pharmaceutical news release