CHICAGO, July 12 /PRNewswire/ -- Paliperidone extended-release (ER) tablets, an investigational, once-daily oral medication, maintained long-term symptom stability in patients with schizophrenia. Data from a multinational, multicenter phase III study were presented today at the Biennial Congress of the Collegium Internationale Neuro-Psychopharmacologicum (CINP). Because paliperidone ER demonstrated robust positive efficacy and a statistically significant delay in the recurrence of symptoms at the planned interim analysis, the study was terminated early on the advice of an Independent Data Monitoring Committee.
The incidence of adverse events (AEs) leading to discontinuation during the double-blind phase of this longer-term trial was low and comparable to placebo. During this phase, four subjects discontinued treatment due to AEs (1 subject in placebo group, 3 subjects in paliperidone ER group).
"The low incidence of recurrence, measured up to 11 months, with the low rate of adverse events leading to discontinuation in the paliperidone ER group relative to placebo, suggest that symptom control can be maintained when treatment is continued," said George Simpson, M.D., professor of research, director, Outpatient Clinic, Keck School of Medicine of the University of Southern California, and one of the study's investigators. "These findings appear to extend and complement the results from previously presented trials of paliperidone ER in the acute treatment of schizophrenia, and strongly suggest that the significant efficacy initially achieved during the first six weeks of treatment can be maintained over the longer term."
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 consistent 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 randomized, double-blind, placebo-controlled, parallel-group study of 207 patients was designed to assess the efficacy of paliperidone ER vs. placebo in the prevention of recurrence of symptoms of schizophrenia and to evaluate paliperidone ER's safety and tolerability. Paliperidone ER (3mg-15mg once daily, with 9mg as the starting dose) was flexibly dosed vs. placebo. Prior to randomization, patients participated in a six-week, open-label stabilization phase.
Treatment with paliperidone ER reduced by more than half the number of recurrence events compared with patients on placebo (22% paliperidone ER, 52% placebo). The patients in the placebo group experienced recurrence of symptoms significantly earlier than those treated with paliperidone ER.
The study demonstrated significant differences in favor of paliperidone ER vs. placebo on the Positive and Negative Syndrome Scale* (PANSS) total score and individual positive PANSS factor scores; Personal and Social Performance (PSP)** Scale; Clinical Global Impression-Severity (CGI-S) score; Schizophrenia Quality of Life Scale (SQLS); and the Sleep Visual Analog Scale (Sleep VAS), which evaluates quality of sleep.
There were three adverse events during the double-blind, controlled phase of the study that occurred at a rate greater than or equal to 5% in either treatment group. These adverse events were psychosis (23% placebo, 7% paliperidone ER), insomnia (6% placebo, 5% paliperidone ER) and aggressive reaction (6% placebo, 1% paliperidone ER). Adverse events related to extrapyramidal symptoms (e.g., involuntary movements, tremors and rigidity) were seen in 7% of paliperidone-treated patients compared with 3% in the placebo group during the double-blind phase.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. submitted a new drug application to the U.S. Food and Drug Administration (FDA) in November 2005, and in May 2006, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities seeking approval. The paliperidone ER submission 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. The OROS extended-release technology was developed by ALZA Corporation. ALZA, Janssen 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.)
Web site: http://www.janssen.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 (PSP) scale is a validated, clinician-rated scale that measures personal and social functioning.
