The results of two studies presented 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. 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, professor of neuroscience and human behaviour, David Geffen School of Medicine, UCLA, and the author of one of the studies.
According to a Johnson & Johnson release, 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 metabolised 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, disorganised thoughts, uncontrolled hostility, excitement and 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 behaviour, socially useful activities including work and study, personal and social relationships, self care and disturbing and aggressive behaviours. This is the first time that the PSP scale has been incorporated into a pivotal clinical trial programme, added the release.
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 five per cent, 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 two million Americans and is characterised by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organised thought.
Johnson & Johnson Pharmaceutical Research and Development, LLC, submitted a new drug application to the Food and Drug Administration on November 29, 2005. The paliperidone ER filing is based on an extensive global clinical development programme 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.