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J&J submits new schizophrenia drug

Published on 08/12/05 at 11:42am

Johnson & Johnson has submitted a new schizophrenia drug to the FDA, and hopes it will succeed one of its biggest earning brands, $3 billion a year Risperdal.

Paliperidone ER is an extended release drug and is closely related to Risperdal (risperidone). J&J says the drug is clinically beneficial for patients who don't respond to treatment with risperidone and has submitted data based on trials of 1,600 patients in 23 countries.

Paliperidone ER is the active metabolite of risperidone and works by fully blocking serotonin receptors, and partially blocks D2 dopamine receptors.

The new drug uses the patented OROS technology, which releases the drug into the bloodstream steadily over a 24-hour period, and is intended to bypass some of the problems experienced with Risperdal.

Launched in 1994 in the US, Risperdal has lost ground to newer competitors in the atypical antipsychotic market - a higher incidence of extra pyramidal side-effects (EPS) and a need for dose titration undermining its sales.

The blockbuster received a further knock-back in May this year when the FDA rejected it for use in two new indications, psychosis in Alzheimer's dementia and the treatment of autism symptoms.

There are two other major new drugs currently in phase III development for schizophrenia. Bifeprunox is a serotonin and dopamine partial agonist developed by Solvay and licensed to Wyeth in the US and Lundbeck in Europe.

Asenapine is a serotonin and dopamine antagonist developed by Akzo Nobel and licensed to Pfizer. Bifeprunox is due to be filed in 2006, with Asenapine expected to be submitted the following year.

 

 

 

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