New antipsychotic effective for schizophrenia

Positive results from the first late-stage clinical trial of the novel antipsychotic drug lurasidone for the treatment of schizophrenia were presented this week at the American Psychiatric Association’s annual meeting in San Francisco.

“A number of the study participants had many prior hospitalizations and lengthy psychiatric histories, but we still found that lurasidone had very promising overall efficacy given the severe nature of illness among many patients in the trial,” Dr. Antony Loebel commented in an interview with Reuters Health.

In addition to good efficacy, lurasidone also did not cause weight gain that has been seen with other second-generation antipsychotic agents.

Lurasidone has been developed by Dainippon Sumitomo Pharma Co., Ltd., and Loebel is vice president of clinical research at Dainippon Sumitomo Pharma America in Fort Lee, New Jersey.

Lurasidone binds very strongly to certain receptors for the brain neurotransmitter serotonin “that we believe are potentially important in improving the symptoms of schizophrenia that are most difficult to treat,” Loebel explained.

The study included 500 patients who were hospitalized because of a flare-up of psychotic symptoms. They were randomly assigned to daily treatment with 40, 80, or 120 milligrams of lurasidone, or an inactive placebo, for six weeks.

The 80-milligram dose was significantly more effective than the placebo in relieving psychotic symptoms, the investigators found.

Loebel said that it reduced hallucinations, delusions, and paranoia, as well as other symptoms of the disorder. “Improvements were noted as early as day 4.”

As mentioned, there was low risk for weight gain and it did not produce any marked increase in the level of the hormone prolactin or interfere with cardiac rhythm, “which makes it a potentially very promising agent for schizophrenia,” Loebel concluded.

The scientist noted that Dainippon Sumitomo Pharma is on track to submit lurasidone for FDA approval in early 2010.

By Karla Gale
NEW YORK (Reuters Health)