Ortho-McNeil-Janssen Pharmaceuticals, Inc. Release: FDA Approves New Injection Site for RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment
TITUSVILLE, N.J., Oct. 9 /PRNewswire-FirstCall/ -- Patients with schizophrenia now have a new administration option for RISPERDAL(R) CONSTA(R) ([risperidone] Long-Acting Injection). The U.S. Food and Drug Administration (FDA) has approved a new injection site, the deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment of patients with schizophrenia. RISPERDAL CONSTA was previously approved as a gluteal injection only.
"For many patients, this injection site may be a good option, as it will provide them with a choice of where to receive their long-acting therapy," said Dr. Mohammed Bari, of Synergy Research Center in San Diego and one of the investigators in the trial.* "The fact that they will just have to roll up their sleeves and get the shot in their arm is going to be a big plus for many patients with schizophrenia."
The application was based on a study showing that the deltoid and gluteal injections of RISPERDAL CONSTA were bioequivalent(a) routes of administration and thus interchangeable. An additional study was conducted that showed the safety and tolerability of RISPERDAL CONSTA injected into the deltoid muscle were similar to the gluteal injections. Both studies were presented earlier this year at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C., 2008.(1, 2)
The new RISPERDAL CONSTA dose packs will now include two separate (non-interchangeable) needles for injection and will be available to U.S. physicians by the end of 2008. The needle for deltoid injection is a smaller gauge and is shorter in length than the gluteal needle. Both are administered every two weeks. Not all patients will be appropriate for the deltoid injection site. As with all medications, it's important that patients discuss their treatment options with their healthcare professional.
RISPERDAL CONSTA is marketed in the U.S. by Janssen(R), 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(R) 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.
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of companies.
Worldwide, it is estimated that one person in every 100 develops schizophrenia,(3) one of the most serious types of mental illness. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally.(4) The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well by disorganized thinking, speech and behavior.
RISPERDAL(R) CONSTA(R) (risperidone) is used for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL(R) CONSTA(R)
Elderly Patients with dementia-related psychosis treated with atypical 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).
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.
* Mohammed Bari, M.D., is a consultant to Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(a) The FDA has defined bioequivalence as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." (FDA, 2003)
References
(1) Ning X, Thyssen A, Quiroz J, et al. Tolerability and safety of long-acting injectable risperidone in chronic schizophrenia subjects using deltoid muscle as an alternative injection site. Presented at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C.
(2) Thyssen A, Ning X, Herben V, et al. Pharmacokinetics of long-acting injectable risperidone injected in deltoid muscle compared to gluteal muscle injection in subjects with schizophrenia. Presented at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, DC
(3) Royal College of Psychiatrists website: http://www.rcpsych.ac.uk/default.aspx?page=1643. Accessed April 14, 2008.
(4) American Psychiatric Association. Let's talk facts about schizophrenia. Available at: http://healthyminds.org/factsheets/LTF-Schizophrenia.pdf. Accessed April 1, 2008.