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Risperdal Consta for schizophrenia better than Zyprexa

Data published in the August 2007 edition of the British Journal of Psychiatry has shown that patients receiving Risperdal Consta (risperidone long-acting injection) experienced higher improvements and significant benefits than patients taking the orally delivered Zyprexa (olanzapine).

Data published in the August 2007 edition of the British Journal of Psychiatry has shown that patients receiving Risperdal Consta (risperidone long-acting injection) experienced a higher incidence of significant clinical benefits, as well as greater improvements in measures of disorganised thinking at 12 months than patients taking the orally delivered Zyprexa (olanzapine).

US-headquartered Johnson & Johnson manufactures Risperdal Consta, while Eli Lilly makes Zyprexa.

Risperdal Consta uses Alkermes' proprietary Medisorb drug-delivery technology, which encapsulates active medication into polymer-based microspheres, allowing the medication to be administered once every two weeks via injection. The microspheres degrade slowly in the body and gradually release the drug at a controlled rate. It will be marketed in the EU by J&J's 100 per cent-owned EU subsidiary, Janssen Cilag.

The randomised, controlled, open label head-to-head study showed that in the long-term, patients might benefit more from treatment with long-acting risperidone injection than with oral olanzapine, despite both treatments showing similar efficacy and tolerability results.

The study recruited patients at 48 centres worldwide including the UK. A total of 318 patients were randomised to long-acting risperidone injection and 300 to olanzapine of which 160 and 187 patients, respectively, completed the 12-month trial.

The primary measure of efficacy was the change in total score on the Positive and Negative Syndrome Scale (PANSS) from base-line to end-point for both short-term (13 weeks) and long-term (12 months) outcomes.

Risperidone long-acting injection achieved clinical improvements (20 per cent minimum reduction in PANSS total scores) in significantly more patients (91 per cent compared with 79 per cent) compared with olanzapine at 12 months.

At the trial's long-term end-point (12 months), a significantly greater improvement on one PANSS factor score (disorganised thoughts) was seen in patients receiving long-acting risperidone than in those receiving olanzapine. Significantly greater improvements were seen in anxiety and depression in the olanzapine group.

The trial data also suggest that long-acting risperidone may have a less pronounced effect on weight gain and body mass index (BMI) than olanzapine. The mean weight gain change in the long-acting risperidone group was 1.7kg compared with 4.0kg in the olanzapine group at the study end-point and BMI was 0.6kg/m2 compared with 1.4kg/m2, respectively.

The study was supported by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) who also completed the statistical analysis.

J&J reported worldwide sales of antipsychotics, which included Risperdal, Risperdal Consta and Invega, of USD 1.2bn, compared with Q1 FY06 sales of USD 1bn.

With FY06 sales of USD 4.4bn, Zyprexa remains Lilly's top-selling drug. However, sales of the drug, which has been on the US market since 1996, have dropped amid FDA safety concerns. While US sales of Zyprexa rose 19 per cent in Q4 FY06, Lilly said this increase was due to higher prices.

Lilly says that US sales have now "stabilised" for Zyprexa, but has not given projections for the drug beyond 2007.

30th September 2008

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