12 Feb 2009 07:00 AM
FDA Issues Complete Response Letter For RISPERDAL(R) CONSTA(R) For Adjunctive Maintenance Treatment Of Bipolar Disorder
Alkermes, Inc. (NASDAQ: ALKS) announced that the Food and Drug Administration (FDA) has asked Alkermes' partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), for additional information regarding the supplemental New Drug Application (sNDA) for RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection). The sNDA, submitted in April 2008, sought approval for RISPERDAL CONSTA for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.
The Agency's complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies.
J&JPRD is currently evaluating the FDA's complete response letter and will work with the Agency to resolve any outstanding questions.
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), and affects 5.7 million, or 2.6 percent, of the American adult population in any given year.1
RISPERDAL CONSTA is marketed in the U.S. by Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL CONSTA was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes' proprietary Medisorb® drug-delivery technology, the RISPERDAL CONSTA formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.
RISPERDAL CONSTA is used for the treatment of schizophrenia.
Important Safety Information For Risperdal® Consta®
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection) 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® CONSTA® 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…
The Agency's complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies.
J&JPRD is currently evaluating the FDA's complete response letter and will work with the Agency to resolve any outstanding questions.
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), and affects 5.7 million, or 2.6 percent, of the American adult population in any given year.1
RISPERDAL CONSTA is marketed in the U.S. by Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL CONSTA was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes' proprietary Medisorb® drug-delivery technology, the RISPERDAL CONSTA formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.
RISPERDAL CONSTA is used for the treatment of schizophrenia.
Important Safety Information For Risperdal® Consta®
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection) 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® CONSTA® 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…
