Johnson & Johnson once-daily paliperidone maintains schizophrenia stability in phase 3 study

By Lisa Kerner

Charlotte, N.C., July 12 - Johnson & Johnson said paliperidone extended-release (ER) tablets, an investigational, once-daily oral medication, maintained long-term symptom stability in patients with schizophrenia in a multinational, multicenter phase 3 study.

Paliperidone ER treatment reduced the number of recurrence events by 52%, compared to 22% for a placebo.

Data from the study were presented Wednesday at the Biennial Congress of the Collegium Internationale Neuro-Psychopharmacologicum.

Paliperidone ER is a new chemical entity providing a consistent release of medication over a 24-hour period.

The double-blind, randomized study of 207 patients was terminated early on the recommendation of an Independent Data Monitoring Committee based on the demonstrated robust positive efficacy and a statistically significant delay in the recurrence of symptoms at the planned interim analysis.

"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," study investigator George Simpson said in a company news release.

The latest findings complement the results of previous trials of paliperidone ER in the acute treatment of schizophrenia and suggest that the significant efficacy initially achieved during the first six weeks of treatment can be maintained over the longer term, officials said.

Johnson & Johnson Pharmaceutical Research and Development, LLC submitted a New Drug Application to the Food and Drug Administration in November 2005, and in May 2006, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities seeking approval for paliperidone ER.

Based in Titusville, N.J., Janssen is a pharmaceutical company dedicated solely to mental health treatment.

Johnson & Johnson is a New Brunswick, N.J., pharmaceutical and health care products company.

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