Healthcare Industry News: paliperidone
News Release - March 30, 2007
Study Suggests INVEGA(TM) Helps Patients With Schizophrenia Maintain Symptom Control52-Week Trial Maintained Improvement in Personal and Social Performance
COLORADO SPRINGS, Colo., March 30 (HSMN NewsFeed) -- Longer-term treatment with INVEGA(TM) (paliperidone) Extended-Release Tablets, a new once daily oral medication for schizophrenia, helped many patients effectively control their symptoms and maintain their improvements in personal and social functioning.
These latest data are from a large, open label, international clinical trial sponsored by Janssen, L.P., the U.S. marketer of INVEGA, and were presented today at the International Congress on Schizophrenia Research (ICOSR). INVEGA was approved last December by the U.S. Food and Drug Administration for the treatment of schizophrenia.
"Schizophrenia imposes serious, lifelong psychological, physical, social, and economic burdens on patients, caregivers and heath care systems worldwide," said Herb Meltzer, MD, Bixler/May/Johnson Professor of Psychiatry & Pharmacology at the Vanderbilt University School of Medicine. "I am encouraged by the results of this pooled analysis because of the need for antipsychotic treatment options that provide effective symptom control, good tolerability, and which help to sustain the ability of patients to function over the long term."
In a pre-planned analysis, researchers evaluated data from 1,083 patients at 168 centers across North America, Europe, Asia, South Africa, and 12 other countries in the open-label extension (OLE) of three similarly designed six- week double-blind studies. In the 52-week OLE phase of the studies, the patients maintained effective symptom control and the improvement in personal and social performance achieved during the six-week double-blind phase.
These studies provided longer-term follow-up to the three previously completed six-week, placebo-controlled trials that demonstrated efficacy and tolerability for INVEGA in the treatment of patients with schizophrenia. In this study, participants were treated with flexible doses of INVEGA (3mg to 15mg once daily, with 9mg as the starting dose) after concluding their previous double-blind study treatment. The study population was segmented into three subgroups based on treatment experience during the previous six-week trials: placebo to INVEGA; INVEGA to INVEGA; and olanzapine to INVEGA.
Because there were more INVEGA active treatment groups in the short-term efficacy trials, most patients entering this OLE study had previously received short-term treatment with INVEGA. Patient groups receiving INVEGA in the short-term efficacy trials were shown to have significantly improved by the end of short-term treatment when they became eligible to enter the OLE study, both in symptoms and in functioning, compared to placebo. In total, 47 percent of patients completed the longer-term 52-week OLE study.
Efficacy analyses included change from baseline to end point in Positive and Negative Syndrome Scale (PANSS)* total score and the Personal and Social Performance (PSP)** scale, a measure of personal and social functioning.
EFFICACY ASSESSMENTS PANSS - Improvements in PANSS total score in all treatment groups were observed over the first 12 weeks of the OLE study and were maintained throughout the remainder of the 52-week trial
- Mean PANSS total scores improved from open-label baseline most notably in patients in the placebo-to-INVEGA group
PSP Scale - The improvements seen in patient personal and social functioning during the six-week placebo-controlled trial, were maintained over the 52-week period.
"The pooled efficacy data suggest to me that long-term treatment with INVEGA helps to sustain symptom control and social functioning," concluded Dr. Meltzer.
Tolerability - The safety profile was generally consistent with the 6-week data. - The most common treatment-emergent adverse events (TEAEs)***, that occurred at a rate of 10 percent or more were: extrapyramidal disorder (movement disorder) (25%), insomnia (14%), headache (12%), and akathisia (restlessness) (11%).
- TEAEs occurred in a total of 76% of participants, although only 7 percent of patients in the trial withdrew from the study due to adverse effects. Total mean change in bodyweight during the 52-week OLE was an average of 1.1 kg.
INVEGA(TM) (paliperidone) Extended-Release Tablets is approved for the treatment of schizophrenia in the U.S.
IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.
The most common side effects that occurred with INVEGA during the six week placebo-controlled trials were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).
One risk of INVEGA is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications may interact with INVEGA. Please inform your healthcare professional of any medications or supplements that you are taking.
A rare but serious side effect that has been reported with this kind of medicine, including INVEGA, is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.
You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your healthcare professional.
Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including INVEGA. Some people may need regular blood sugar testing.
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.
Some people taking INVEGA 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 may be reduced or it may go away over time.
You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. Some people taking INVEGA have these side effects. If you have these symptoms, talk to your healthcare professional.
Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking INVEGA. Do not breast-feed if you are taking INVEGA.
INVEGA may affect your driving ability, therefore, do not drive or operate machines before talking to your healthcare professional.
INVEGA may affect alertness and motor skills; use caution until the effect of INVEGA is known. Avoid alcohol while on INVEGA.
INVEGA 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.
INVEGA should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.
Please see full important U.S. prescribing information for INVEGA at http://www.janssen.com
Worldwide, it is estimated that 1 person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well by disorganized thinking.
Janssen, L.P., 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, L.P., visit http://www.janssen.com; for more information on INVEGA, visit www.INVEGA.com.
Web sites: http://www.janssen.com; http://www.invega.com; http://www.alza.com;
* The PANSS is a validated, multi-item inventory composed of five factors: positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement and anxiety/depression.
** The Personal and Social Performance scale (PSP) is a validated, clinician-rated scale that measures personal and social functioning. *** A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in intensity or frequency following exposure to the treatments.
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