New Drugs for Schizophrenia: Iloperidone and Bifeprunox

New Drugs for Schizophrenia: Iloperidone and Bifeprunox

Schizophrenia is a serious mental illness. People with this illness have disturbed and disorganized thinking, language, and behavior. They may see, hear, or feel things that aren't really there. Sometimes the speech of a person with schizophrenia makes no sense. Schizophrenia usually causes serious problems in day-to-day living.


The term schizophrenia means "split mind." Those who have it seem to have normal mental function in some areas but are very disturbed in others. (For example, a person may talk in bizarre ways but be able to do math.) Schizophrenia is not the same as multiple personality disorder. People with schizophrenia do not have different personalities.

About 1% of people have schizophrenia in their lifetimes. It affects men and women equally.

Medicines are the most important part of the treatment. There are many medicines that can make a big difference in your life. These medicines can cause some side effects, but you and your health care provider will watch for them and adjust the medicine if needed.

In some cases, specific psychiatric medications are approved by the Food and Drug Administration (FDA) to treat a particular type of mental illness. However, medications are often used to treat conditions for which they're not officially approved — a common and perfectly legal practice called off-label use. For instance, fluoxetine (Prozac, Prozac Weekly) is FDA approved to treat depression, panic disorder and several other mental illnesses. It's not specifically approved to treat generalized anxiety disorder, but it may be prescribed to treat that disorder.

An experimental treatment for schizophrenia produced fewer worrisome side effects compared with drugs currently in use, its makers said.

The drug, bifeprunox, is being developed jointly by Wyeth, H. Lundbeck A/S of Denmark and Solvay Pharmaceuticals Inc., a unit of Belgium's Solvay SA.

The companies, presenting results from mid-stage and late-stage studies of the drug at a major medical meeting, said it was effective in treating acute symptoms of schizophrenia, but less so than other drugs.

However, in six-week trials, it helped stable patients -- those whose symptoms were already under control - to lose weight and improve blood cholesterol, which are common problems with current treatments.

The results were in line with comments made in October by officials at Wyeth who suggested the drug was less effective than Johnson & Johnson's Risperdal and Eli Lilly and Co.'s Zyprexa but offered a better safety profile for patients who are already stable.

Recently,Vanda Pharmaceuticals Inc. said its schizophrenia treatment was effective in a late-stage clinical trial, putting the biopharmaceutical closer to filing a New Drug Application with the Food and Drug Administration in late 2007.

The compound, iloperidone, is an atypical antipsychotic, and was tested in two doses in a four-week trial with 604 patients with schizophrenia, a chronic, debilitating mental disorder.

"If approved, bifeprunox may be a valuable treatment option for stable patients with schizophrenia," Dr. Daniel Casey, professor of psychiatry and neurology at Oregon Health and Science University, said in a statement.

"These are important new findings because some obstacles, including side effects associated with current treatments, can derail the optimal long-term care of patients with schizophrenia," he said.

Side effects are a significant problem for patients with schizophrenia -- a group of psychotic diseases marked by delusions and hallucinations -- who must take drugs all their lives.

According to the data, iloperidone demonstrated statistically significant improvement compared to placebo on the Positive and Negative Symptom Scale (PANSS), the trial's primary endpoint. Positive symptoms of schizophrenia include hallucinations, delusions, racing thoughts and other psychotic symptoms, while negative symptoms include moodiness, anhedonia (inability to feel pleasure), loss of interest, eating and sleep disturbances, and difficulty concentrating.

The company said iloperidone also achieved significant efficacy on the positive and negative symptom subscales of PANSS.

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