Johnson submit schizophrenia drug to FDA

Johnson & Johnson (J&J) has made a new drug application (NDA) to the US Food and Drug Administration (FDA) for its schizophrenia drug paliperidone.

The drug, which takes the form of a daily oral treatment, uses a patented 24 hour release technology. The NDA filing comes after clinical trials of the drug with over 1,600 individuals across the world.

J&J said that it’s wholly owned subsidiary Janssen LP would market the drug in the US. The company is planning on making regulatory submissions in other regions soon, but it has not yet settled on a commercial name for the drug.

However, analysts have said that whilst paliperidone is likely to be successful in the market place, J&J’s real challenge will come when its most lucrative schizophrenia drug, Risperdal, goes generic.

The patent for the treatment, which is also sold by Janssen, is due to expire in 2007 allowing generic versions of the drug. Mike Bailey of Bear Stearns told United Press International that the NDA filing was an attempt by J&J to counter expected losses from generic Risperdal.

He said he expected paliperidone to launch in the US by the end of 2006, and added that it should make $30 million in sales.

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