Janssen-Cilag submits new schizophrenia drug
pharmafile | May 8, 2006 | News story | Sales and Marketing |Â Â Â
A new slow-release drug for schizophrenia has been filed for approval in Europe by Jannsen-Cilag, the manufacturers of top-selling Risperdal.
Paliperidone ER is closely related to Risperdal (risperidone) but the company 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 2005 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, asenapine and bifeprunox.
Asenapine is a serotonin and dopamine antagonist developed by Akzo Nobel and licensed to Pfizer. Asenapine is expected to be submitted in 2007.
Bifeprunox is a serotonin and dopamine partial agonist developed by Solvay and licensed to Wyeth in the US and Lundbeck in Europe.
The companies say analysis of data has taken longer than expected, with filing of the drug in Europe now forecast for 2008, depending on the completion of extra phase III comparative clinical work.
