Schizophrenia Daily News Blog

Paliperidone - J&J Schizophrenia Drug, Gets Conditional Approval

Last Friday, Johnson & Johnson (J&J) said U.S. health regulators (the FDA) would not approve the company's next-generation schizophrenia medication, paliperidone extended-release, until certain conditions are met.

UPI reported that "analysts were cautiously optimistic the company would resolve the situation relatively quickly. The FDA's decision delays final approval of paliperidone by at least three months, but analysts said they expect the drug to hit the market before the patent on J&J's other antipsychotic, Risperdal, expires in December 2007."

In a related report, The Wall Street Journal stated that J&J plans to market the new treatment as a significant improvement over Risperdal and a result, the pharmaceutical company and paliperidone have drawn a close look from the medical community and raised doubts on Wall Street.

The Wall Street Journal suggested that Risperdal's "rebirth as paliperidone" is just one example of many efforts by pharmaceutical companies to extend the sales and profits from very successful drugs whose patents are about to expire by slightly modifying (then re-patenting the slightly different new drug) and then relaunching the new medication under a new name. Given that the Risperdal patent lapses at the end of 2007, generic Risperdal, or risperidone, could be available as soon as the end of next year or 2008.

It was further reported by the Wall Street Journal that:

In presentations at medical meetings over the past year, J&J has said that, as expected, paliperidone was more effective than a placebo in relieving symptoms of schizophrenia at six weeks, delayed recurrence of symptoms when measured as long as 11 months, and was well tolerated. Common side effects included rapid heart beats and insomnia.

Paliperidone "doesn't represent any kind of quantum leap in efficacy or tolerability" over existing antipsychotic drugs, said Norman Sussman, a professor of psychiatry at New York University, who wasn't involved in testing it. He said he expects J&J's marketing of "fine distinctions" will sway some doctors but said he plans to use it mainly for patients who have had bad reactions or haven't responded to other drugs.

J&J has cited dissatisfaction with existing medicines as an opening for paliperidone to gain traction. "We need more choices, and we need better medicines," said John Kane, a psychiatrist at Zucker Hillside Hospital in New York and a paid consultant to J&J. "No one medicine is going to work for everyone."