Mental Health

FDA Grants Approval For Use Of RISPERDAL(R) CONSTA(R) As Both A Monotherapy And Adjunctive Therapy In The Maintenance Treatment Of Bipolar I Disorder

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. 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. 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. About J&JPRD Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a member of the Johnson & Johnson family of companies, the world"s most broadly-based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. About Janssen Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of companies. IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R) Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS. Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar medications. TD 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 RISPERDAL(R) CONSTA(R) and 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(R) CONSTA(R). 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. RISPERDAL(R) CONSTA(R) and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown. Some people taking RISPERDAL(R) CONSTA(R) may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional"s dosing instructions, this side effect can be reduced or it may go away over time. RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. RISPERDAL(R) CONSTA(R) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures. Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional. Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be exercised when RISPERDAL(R) CONSTA(R) is administered to a nursing woman. RISPERDAL(R) CONSTA(R) may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm. Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL(R) CONSTA(R). RISPERDAL(R) CONSTA(R) In a study of people taking RISPERDAL(R) CONSTA(R), the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth. If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk with your doctor. IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R) WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis. Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with

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