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This is an archive article published on September 3, 2007

Drug provides hope of schizophrenia breakthrough

In a clinical trial of about 200 patients, an experimental drug from Eli Lilly reduced schizophrenia symptoms without the serious side effects of current treatments

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In a clinical trial of about 200 patients, an experimental drug from Eli Lilly reduced schizophrenia symptoms without the serious side effects of current treatments, according to a paper published on Sunday in the journal Nature. The drug must still be evaluated on many more patients to test for the possibility of side effects that have not yet emerged, and it is at least three to four years from completing regulatory review.

But schizophrenia researchers said the trial’s results were surprising and impressive, especially since the drug works in a different way from existing anti-psychotic medicines, all of which have serious side effects, including substantial weight gain and tremors.

Lilly will begin a larger clinical trial for the drug this month. If that trial confirms the results seen so far, the new drug could mark a breakthrough in the treatment of schizophrenia — and open the way to a broad new class of treatments for the disease. Schizophrenia, a devastating mental illness that affects 1 percent of adults, or about 2.5 million in the United States, usually begins in the late teens or 20s and is marked by psychotic delusions as well as social withdrawal and cognitive impairment.

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“This is potentially one giant step forward for patients,” said Dr Jeffrey Lieberman, chairman of the psychiatry department at Columbia and the lead investigator on a federally sponsored clinical trial of schizophrenia medicines. “This drug may turn out to be not just a comparably good anti-psychotic agent, but a better anti-psychotic agent.” He has not been involved with the development of the medicine and does not receive any payments or consulting fees from Lilly.

The new drug also has the potential to be a blockbuster for Lilly. Medicines for schizophrenia and bipolar disorder are the fourth-best selling class of medicines in the United States, with sales of $12 billion in the United States and $18 billion worldwide last year.

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