Study Suggests That Investigational Drug Paliperidone ER Improves Sleep Onset

Main Category: Schizophrenia
Also Included In: Sleep / Sleep Disorders / Insomnia;  Clinical Trials / Drug Trials
Article Date: 20 Sep 2006 - 0:00 PDT

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Paliperidone extended-release (ER) tablets, an investigational, once-daily oral medication for schizophrenia, significantly improved sleep onset, sleep continuity, and duration of sleep in schizophrenia patients diagnosed with schizophrenia- related insomnia when compared with placebo. Data from this study were presented today at the 19th Congress of the European College of Neuropsychopharmacology (ECNP).

This study was a multi-center, double-blind, randomized, placebo- controlled study of 36 patients with schizophrenia-related insomnia (17 paliperidone ER, 19 placebo; mean age 32.2 years) conducted at eight centers in Europe. The study consisted of a screening period that lasted up to 14 days, a washout phase of up to seven days, and three baseline days. Patients were administered 9 mg paliperidone ER or matching placebo each morning for two weeks.

"This is the first time a placebo-controlled study of this size was designed to specifically assess multiple parameters of sleep in a group of patients with schizophrenia who have specific complaints of insomnia," said Remy Luthringer, PhD., lead investigator of the study. "In addition to the robust efficacy and tolerability profile observed in previously released data on paliperidone ER in the treatment of schizophrenia, we found in this study that patients receiving paliperidone ER fell asleep faster and stayed asleep longer than those on placebo. This suggests that paliperidone ER may provide an important additional benefit for the many patients with schizophrenia in whom sleep disturbance is a problem."

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 smooth blood plasma levels. Moreover, paliperidone ER is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.

Treatment with paliperidone ER, compared with placebo, resulted in clinically meaningful and statistically significant improvements in mean sleep measurements in several domains. These multiple improvements included a robust mean reduction of over half an hour in the time required to first fall asleep, and a reduction of more than 40 minutes in the time required to remain persistently asleep. Enhanced sleep continuity and duration were demonstrated by an increase in total sleep time approaching an hour (53 minutes). Stage two sleep, in which normal subjects spend nearly half their sleep time, was increased in schizophrenic patients receiving paliperidone ER by nearly an hour (51 minutes). Rapid eye movement sleep (REM), which is typically associated with the dream state and is speculated to be associated with memory consolidation, increased 18 minutes versus placebo.

The most commonly reported adverse events were extrapyramidal symptoms (involuntary movements, tremors, rigidity) and headache in the paliperidone ER group and hyperkinesias, psychosis, somnolence, and nausea in the placebo group.

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

submitted a new drug application to the U.S. 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 to market the medication. 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 U.S. 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 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings to request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward- looking statements as a result of new information or future events or developments.)

Johnson & Johnson Pharmaceutical Research and Development
http://www.janssen.com

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