A novel new antipsychotic drug is proving effective in clinical trials with fewer side effects compared to the commonly used Risperdal (risperidone) for the treatment of schizophrenia.
The first-in-class antipsychotic is known as ITI-007 and is made by Intra-Cellular Therapies Inc. It is a unique, multitasking drug with a different pharmacological profile than any other antipsychotic. Phase 2 studies showed it was effective and demonstrated reduced motor and metabolic side effects compared to Risperdal, a drug made by Johnson & Johnson subsidiary Janssen Pharmaceuticals.
What makes ITI-007 effective is that it combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, glutamatergic modulation, and serotonin reuptake inhibition. The medication targets sleep quality and antipsychotic and antidepressant activity. Developers say it can improve social function in some patients as well.
Study participants received either 60 mg doses or 120 mg doses of the drug or a placebo. Researchers noted that patients who were treated with ITI-007 had lower metabolic measures and less weight gain than patients treated with Risperdal. The drug also did not affect cardiovascular function and was not associated with an increased heart rate.
It’s still too early to determine the scope of side effects with ITI-007, but researchers say studies offer hope to patients, especially those who cannot tolerate Risperdal side effects. Risperdal, which is also used to treat pediatric patients, has been linked to gynecomastia, a condition in which boys and young men grow breasts.
The new therapy is only being tested on adults, and has entered phase 3 clinical trials, where side effects can be better understood.