Eli Lilly's new drug reduces schizophrenia symptoms

An experimental drug by a global pharmaceutical company - Eli Lilly indicated promise in reducing schizophrenia symptoms without serious side effects, according to data from a clinical trial presented on Sunday.

In the clinical trial data, experts noticed that patients using Lilly’s investigational treatment, dubbed LY2140023, had statistically significant improvements in symptoms and few side effects versus those taking placebos.

Financed by the Indiana, United States based Lilly and published in the September issue of the journal Nature Medicine, the latest study involved 196 patients with schizophrenia, a mental illness that affects about 2 million Americans, of which 118 patients completed the four weeks of planned study treatment.

After more than one month’s observation, the experts found that patients on the drug had significantly fewer symptoms of schizophrenia, than those on a placebo or olanzipine (Zyprexa), a commonly prescribed anti-psychotic medication. The differences came after one week, the researchers yesterday stated in the paper.

In the study, researchers found that the new medicine LY2140023 was as effective as Zyprexa in reducing both "positive" and "negative" symptoms such as hallucinations and social withdrawal respectively.

What made the new drug candidate different from all other antipsychotics was its target in the brain. Unlike other anti-psychotic drugs on the market, which block the uptake of a naturally occurring chemical called dopamine, the new compound affects glutamate, involved in learning and memory.

Lilly’s new drug LY2140023 also did not produce some of the adverse side effects of currently available schizophrenia treatment, like involuntary movement, muscle stiffness or weight gain.

“This is potentially one giant step forward for patients,” said Dr. Jeffrey Lieberman, the lead investigator on a federally sponsored clinical trial of schizophrenia medicines and Chairman of the psychiatry department at Columbia.

“This drug may turn out to be not just a comparably good antipsychotic agent, but a better antipsychotic agent,” added Dr. Lieberman, who has not been involved with the development of Lilly’s new medicine and does not receive any payments or consulting fees from the drug company.

With such potential effects, experts think the new drug could replace Lilly’s top-selling Zyprexa, which was introduced in 1996 by the company as a breakthrough with fewer side effects than older drugs. But this antipsychotic medicine was criticized for its severe side effects, like weight gain. The American Diabetes Association has linked it to diabetes.

Approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia, acute mania in bipolar disorder, agitation associated with schizophrenia and bipolar disorder, and as maintenance treatment in bipolar disorder and psychotic depression, Zyprexa’s US patent ends in 2011.

Zyprexa, Lilly’s top-selling drug with $4.3 billion in 2006 sales, faces competition from less expensive copies in Canada and Germany, according to its manufacturer.

Lilly is scheduled to begin a new and larger clinical trial for the drug this month.

"Additional and longer-term studies are needed to confirm and extend these exciting initial findings. However, these data suggest that (the drug) may provide a new alternative for the treatment of this often devastating condition," said Steven Paul, Lilly's executive vice president of science and technology in a statement.