TITUSVILLE, N.J., Dec. 14 /PRNewswire/ -- The results of two studies presented this week at a major scientific meeting showed that the investigational, once-a-day oral medication, paliperidone extended release (ER) tablets, was effective in significantly improving symptoms in patients with schizophrenia versus those treated with placebo. The studies also demonstrated improvement in personal and social functioning, an important treatment goal in assessing patients’ progress. Discontinuation rates due to adverse events for all paliperidone ER dose groups were comparable to placebo.
“The data presented at this meeting offer the medical community its first look at the profile of paliperidone ER in the treatment of the clinical symptoms of schizophrenia, and its impact on patients’ personal and social functioning,” said Stephen Marder, M.D., Professor of Neuroscience and Human Behavior, David Geffen School of Medicine, UCLA, and the author of one of the studies.
Paliperidone ER, a new chemical entity, is the first antipsychotic to use the patented OROS extended release technology, which provides a steady release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations. In addition, paliperidone ER is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.
Paliperidone ER demonstrated significant improvements in mean total scores of the Positive and Negative Syndrome Scale (PANSS) versus placebo for all doses tested in both studies. PANSS is a validated, multi-item inventory composed of five factors: positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility / excitement and anxiety / depression.
Paliperidone ER also demonstrated improvements in the Personal and Social Performance scale (PSP) versus placebo in both trials, with statistical significance achieved in four of the five paliperidone ER treatment arms. The PSP is a validated, clinician-rated scale that measures personal and social functioning in four domains of behavior -- socially useful activities including work and study, personal and social relationships, self care and disturbing and aggressive behaviors. This is the first time that the PSP scale has been incorporated into a pivotal clinical trial program.
The overall incidence of treatment emergent adverse events (TEAEs) pooled across both studies was comparable to placebo. The specific TEAEs, which occurred at a rate of greater than or equal to 5%, were headache, akathisia, extrapyramidal disorder, sedation, insomnia, agitation, anxiety, tachycardia and sinus tachycardia for paliperidone ER, and headache, sedation, insomnia, agitation and anxiety for placebo.
Schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.
Johnson & Johnson Pharmaceutical Research and Development, LLC, submitted a new drug application to the Food and Drug Administration (FDA) on November 29, 2005. The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. If approved by the FDA, paliperidone ER will be marketed in the United States by Janssen, L.P., a wholly-owned subsidiary of Johnson & Johnson. The trade name for the product has yet to be determined.
Janssen, L.P. is based in Titusville, N.J., and focuses exclusively on pioneering solutions for healthy minds and currently markets prescription medications for the treatment of schizophrenia and bipolar mania. For more information about Janssen, L.P. 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 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(b) of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K are available online at http://www.sec.gov/ or on request from Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.)
Johnson & Johnson Pharmaceutical Research and Development, LLC
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