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Invega licensed in UK as new treatment for schizophrenia

Janssen-Cilag wins EMEA marketing authorisation for schizophrenia treatment Invega

Danish pharmaceutical company, Janssen-Cilag, has received marketing authorisation from the European Medicines Agency (EMEA) for Invega (paliperidone prolonged-release tablets) for the treatment of schizophrenia.

The once-daily atypical antipsychotic medication has shown in clinical trials that it reduces symptoms which disrupt the lives of people with schizophrenia and has also shown to be generally well tolerated.

Invega is the first and only atypical antipsychotic treatment for schizophrenia to use US drug delivery firm Alza's Oros prolonged-release technology, which provides a consistent release of medicine over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations. The steady release of medicine provides simple once a day dosing, without the need for dose titration.

The Oros system targets specific areas of the gastrointestinal tract, providing more efficient drug absorption and enhanced bioavailability, while eliminating the variability of drug absorption and metabolism caused by gastric pH and motility.

The authorisation of Invega was based on results of an extensive clinical development programme enrolling over 1,200 patients in 23 countries around the world as part of three pivotal studies. 

The primary measure of efficacy was the Positive and Negative Syndrome Scale (PANSS) which measures the severity of positive and negative symptoms. Patient functioning and other measures of efficacy and tolerability were also included in the trial data supporting authorisation of Invega.

Key findings of the clinical programmes:

ï All doses of INVEGA demonstrated significant improvements in mean total score and in each of the five factor scores of the PANSS versus placebo

ï Many patients on INVEGA experienced statistically significant symptom improvement versus placebo as early as day four, at the recommended 6mg dose

ï As early as Day Four, INVEGA 6mg demonstrated a statistically significant separation from placebo on the total PANSS maintained for the remainder of the study.

Risperdal is Johnson & Johnson's (J&J) most important drug, with FY05 sales of USD 3.5bn (EUR 2.7bn). A Datamonitor report stated that the patent expiry will lead to a loss in revenues of over USD 1bn (EUR 734m) in 2008, due to generic sales erosion. Oral Risperdal came off patent in 2006.

Second-generation antipsychotics are popular with psychiatrists due to their decreased propensity to cause extrapyramidal side-effects, including slurred speech, tremors, paranoia and anxiety.

However, results of two studies, CATIE and CUtLASS 1, which examined the efficacy of atypical antipsychotic drugs found that second generation drugs are no more effective or tolerable than older drugs.

Report uncovers heart rhythms changes
Furthermore, a March 2007 analysis conducted by the Carlat Psychiatry Report found that Invega caused a potentially dangerous change in some patients' heart rhythms. QT interval prolongation has been associated with fatalities due to other medications with this side effect. Invega also caused rapid heart beat in over 12 per cent of patients taking the compound.

The newsletter added that while Invega was marketed by Janssen as a "new treatment for schizophrenia", the drug was actually a liver by-product of risperidone isolated in a laboratory and packaged in an extended-release form. Thus, patients taking the original medication, risperidone, produced therapeutic quantities of paliperidone through normal liver metabolism. Janssen defended Invega by stressing that it was not metabolised by the liver and so could be given safely to patients with liver disease.

Antipsychotics represent a USD 10bn (EUR 7.3bn) market for the pharmaceutical industry, while Janssen's original antipsychotic, Risperdal, will lose patent protection in June 2008, so Invega is the company's best hope to maintain its presence in the therapeutic sector.

4th July 2007

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