Johnson & Johnson Pharmaceutical Research and Development, LLC Release: Clinical Study Of Investigational Drug Paliperidone ER Demonstrated Efficacy And Tolerability In The Treatment Of Patients With Schizophrenia
TORONTO, May 23 /PRNewswire/ -- A multinational, multicenter phase III study presented today at the 159th annual meeting of the American Psychiatric Association showed that the investigational, once-a-day oral medication, paliperidone extended release (ER) tablets, was effective in significantly reducing positive and negative symptoms in people suffering from schizophrenia versus those treated with placebo. Importantly, this study also demonstrated improvement in patient functioning, as measured by the Personal and Social Performance scale* (PSP) across a wide range of doses. This is the first time that the PSP scale has been incorporated into a pivotal clinical trial program. Additionally, discontinuation rates due to adverse events for all paliperidone ER dose groups were comparable to placebo.
"These data reinforce the findings of two other pivotal trials conducted for paliperidone ER," said David P. Walling, PhD, chief clinical officer for Collaborative NeuroScience and one of the study's investigators. "The results of this trial suggest both strong efficacy and good tolerability. If approved by the U.S. Food & Drug Administration, paliperidone ER may offer clinicians an important new treatment option with the potential to help patients control their symptoms and improve functioning."
Paliperidone ER, a new chemical entity, is the first and only atypical antipsychotic to use the OROS(R) extended release technology. This technology provides a continuous release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations. Moreover, paliperidone ER is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.
This double-blind, parallel-group, dose-response study of 618 patients was designed to assess the efficacy, safety and effect on functioning of paliperidone ER at daily doses of 3mg, 9mg or 15mg vs. placebo.
All three doses of paliperidone ER demonstrated significant improvements in mean total scores and in each of the five factor scores of the Positive and Negative Syndrome Scale (PANSS) versus placebo.
The PANSS is a validated, multi-item inventory composed of five factors: positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement and anxiety/depression.
All doses of paliperidone ER also demonstrated significant improvements in patient functioning versus placebo as measured by the PSP scale. The PSP scale 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 a specific measure of social functioning (PSP scale) has been incorporated consistently into a pivotal clinical trial program for a drug to treat schizophrenia.
Discontinuation rates due to adverse events for all paliperidone ER dose groups were low and comparable to placebo (4% for placebo and for paliperidone ER: 2% for 3mg, 5% for 9mg and 3% for 15mg, respectively). The specific treatment-emergent adverse events** (TEAEs) associated with paliperidone ER, which occurred at a rate of greater than or equal to five percent and twice that of placebo in any of the dosing arms were somnolence, agitation, headache, extrapyramidal disorder, hyperkinesia and dizziness.
Johnson & Johnson Pharmaceutical Research and Development, LLC submitted a new drug application to the U.S. Food and Drug Administration (FDA) on November 29, 2005. And earlier this month, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities seeking approval. The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Upon approval by regulatory authorities, paliperidone ER will be marketed in the United States by Janssen, L.P. and in Europe by Janssen-Cilag. Both companies, and J&JPRD are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.
Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. It is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking.
Janssen, L.P., based in Titusville, N.J., is the only large pharmaceutical company in the US dedicated solely to mental health. The company 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 1, 2006. 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.)
* 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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