FDA Approves new Schizophrenia Drug Olanzapine (Zyprexa) - More news
The Food and Drug Administration approved a new drug for schizophrenia Tuesday that doctors say could help patients who don't respond to existing medicines. Eli Lilly & Co.'s olanzapine, to be sold under the brand name Zyprexa, has not yet been adequately compared to existing medicines, so the FDA would not let the company advertise the drug as superior.
But psychiatrists have high hopes for olanzapine because it is chemically similar to an older medicine that often proved best at controlling schizophrenia -- except that many patients couldn't tolerate its side effects and thus had to take less effective drugs.
Olanzapine appears to have the benefits of that older drug, clozapine, without the side effects, explained Dr. Alan Schatzberg, Stanford University's chairman of psychiatry. "It's a potential breakthrough of tremendous magnitude," said Schatzberg, although he cautions that the drugs must be directly compared.
Lilly planned to ship olanzapine to wholesalers Wednesday, meaning some pharmacies could have supplies by the end of the week. The wholesale price for a 60-day supply is $387, and some analysts have predicted the drug could generate annual sales of up to $1 billion by 2000. As much as 1 percent of the population may suffer from schizophrenia, a mental illness characterized by hallucinations, delusions, withdrawal and inability to feel pleasure. Standard schizophrenia drugs carry the risk of causing movement troubles such as rigidity, Parkinson's disease-like tremors and involuntary movements that left some patients flailing their arms and biting through their tongues. They also poorly treated some schizophrenia symptoms such as withdrawal.
Clozapine changed schizophrenia treatment by fighting all the symptoms and largely avoiding the movement troubles, but it posed another serious risk: A potentially fatal blood illness that left patients having blood drawn every week to ensure they weren't stricken. The challenge was to develop better drugs that avoided the side effects of both standard therapy and clozapine. The first, Risperdal, hit the market in 1994, and manufacturer Janssen Pharmaceutical announced Tuesday that it had become the nation's most prescribed antipsychotic.
Olanzapine may prove to be the second generation of these better drugs because it appears to affect even more areas of the brain than Risperdal, psychiatrists said Tuesday. In six-week studies of 400 patients comparing olanzapine to a dummy pill, olanzapine eased all standard symptoms of schizophrenia. In another study, of 1,996 patients, about half of whom were Americans, olanzapine proved at least as effective as standard therapy, with a drug called haloperidol, and better at treating some symptoms.
Olanzapine poses no risk of the fatal blood illness that competitor clozapine does, Lilly said. Low doses appeared not to cause the troubling movement side effects, although the risk of movement problems did rise once patients reached the recommended daily dose of 10 milligrams, said FDA spokeswoman Susan Cruzan.
Also, olanzapine can cause sedation, dizziness and weight gain, Lilly
said. "Olanzapine is the next step up," said Emory University
psychiatric chief Dr. Charles Nemeroff, who noted it is the first in a
batch of similar new drugs, by such makers as Abbott, Pfizer and Sandoz,
in the pipeline.
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