TITUSVILLE, N.J., July 31 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved the first and only antipsychotic for the acute treatment of schizoaffective disorder. INVEGA(R) (paliperidone) extended-release tablets were approved for the acute treatment of schizoaffective disorder either as monotherapy or adjunctive therapy to mood stabilizers and/or antidepressants. INVEGA(R) was approved in 2006 for the treatment of schizophrenia. Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, markets INVEGA(R) in the U.S.
Differentiating schizoaffective disorder from schizophrenia or a mood disorder can be difficult. Patients with schizoaffective disorder experience the psychosis characteristic of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression. Among people who frequently use mental health services, schizoaffective disorder may account for approximately 24 percent of cases.(1)
"Schizoaffective disorder can be challenging to diagnose because of the broad range of symptoms patients experience," said Nina Schooler, Ph.D.,* SUNY Downstate Medical Center. "The approval of INVEGA(R) is exciting as it is the only antipsychotic treatment proven in double-blind, randomized, placebo-controlled trials to be efficacious with a demonstrated tolerable safety profile treating both the psychotic and affective symptoms present in this understudied population."
The approval is based on two international, randomized, double-blind, placebo-controlled studies of patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms. In the first six-week study, patients received flexible doses of INVEGA(R) (3-12 mg once daily). In the other study, patients were assigned to one of two dose levels of INVEGA(R): 6 mg with the option to reduce to 3 mg, or 12 mg with the option to reduce to 9 mg. In addition to study medication, subjects were permitted to receive concomitant treatment with a mood stabilizer and/or antidepressant, provided these medications had been given at a stable dose within 30 days of screening. Approximately half the subjects enrolled received ongoing treatment with a mood stabilizer and/or antidepressant during the studies. The most commonly used mood stabilizers were valproate and lithium. The most commonly used antidepressants were SSRIs and SNRIs.
Efficacy was evaluated using the positive and negative symptom scale (PANSS), a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression. As secondary outcomes, mood symptoms were evaluated using the Hamilton Depression Rating Scale (HAM-D-21) and the Young Mania Rating Scale (YMRS).
The INVEGA(R) group in the flexible-dose study (dosed between 3 and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of INVEGA(R) in the 2 dose-level study (12 mg/day with option to reduce to 9 mg/day) were each superior to placebo in the PANSS. Numerical improvements in mood symptoms were also observed, as measured by the HAM-D-21 and YMRS. In the lower dose group of the 2 dose-level study (6 mg/day with option to reduce to 3 mg/day), INVEGA(R) was not significantly different from placebo as measured by the PANSS.
The most common adverse events (incidence greater than or equal to 5% and at least twice that for placebo) were extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increase, and nasopharyngitis.
"Schizoaffective disorder is a chronic, disabling condition," said Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development. "This new indication for INVEGA(R) further demonstrates Janssen's commitment to helping people with serious mental illnesses."
IMPORTANT SAFETY INFORMATION FOR INVEGA(R)
INVEGA(R) is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA(R) in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.
Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA(R) and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.
Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGA(R) and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your 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 total dose received. This condition can also develop after a short period of treatment at low doses but this is less common. There is no known treatment for TD but it may go away partially or completely if the medicine is stopped.
One risk of INVEGA(R) is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
High blood sugar and diabetes have been reported with INVEGA(R) and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling weak or hungry.
People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their healthcare professional before taking INVEGA(R).
Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.
INVEGA(R) and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.
INVEGA(R) and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
INVEGA(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.
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.
INVEGA(R) can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA(R), be careful driving a car, operating machines, or doing things that require you to be alert.
The most common side effects that occurred with INVEGA(R) in the treatment of schizoaffective disorder were: Abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes, sleepiness, heartburn, constipation, weight increase, and sore throat.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
If you have any questions about INVEGA(R) or your therapy, talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INVEGA(R), an atypical antipsychotic medication, was first approved in the U.S. in December 2006. Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, markets paliperidone ER as INVEGA(R). It is approved for the acute and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U. INVEGA(R) is now the only medication approved to treat schizoaffective disorder.
INVEGA(R) was discovered by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), 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. More information can be found at http://www.jnjpharmarnd.com.
Janssen(R), 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, schizoaffective disorder and the treatment of symptoms associated with autistic disorder. Ortho-McNeil-Janssen Pharmaceuticals, Inc, is a member of the Johnson & Johnson family of companies. For more information about Janssen(R), visit http://www.janssen.com/.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
(1)Kent, S., Fogarty, M., Yellowlees, P. (1995). Heavy Utilization of Inpatient and Outpatient Services in a Public Mental Health Service. Psychiatric Services, (46) 12, 1254 - 1257.
*Dr. Nina Schooler is a paid consultant for Janssen(R).
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