A new investigational antipsychotic drug, ITI-007, entered its first phase 3 study with some promising results.
According to Medscape, findings from an earlier large phase 2b trial proved that the investigative drug can help significantly reduce symptoms of acute psychosis following 4 weeks of usage.
At the same time, the drug shows no side effects when compared to a placebo, as the Institute of Psychiatric Services (IPS) revealed at the Mental Health Services 2016 Conference.
Although the drug was very well tolerated during a second phase 3 study, clinicians found no difference in efficacy in comparison to a placebo.
Essentially, Christoph Correll, MD, the lead investigator, explains how the dopamine blockers in the drug functions for acutely ill patients, and how the drug behaved similarly to risperidone, or Risperdal — a commonly prescribed atypical antipsychotic drug.
Dr. Correll also stated: “But the uniqueness of this medication is that it actually has placebo-like tolerability except for a bit of sedation, and even in the most recent phase 3 study, where neither the 60-mg nor the 120-mg dose of ITI-007 separated from placebo, there was again a placebo-level side effect profile and significantly fewer side effects than risperidone.”
Moreover, during the first phase 3 trial of the new drug, 450 patients with acute symptoms of schizophrenia were randomly given 60 mg once a day, 40 mg once a day or a placebo.
“At a dose of 60 mg, the drug met the primary endpoint of the study, and separated as early as 1 week from placebo and maintained efficacy at every time point on the PANSS total score (P = .022),” the study showed.
Both doses of ITI-007, 60 and 40 mg, were seen as superior to placebo with respect to scores on the PANSS positive symptom subscale. This superiority was seen again and again throughout the entire length of the study, clinicians concluded.
It was quickly noted that both doses showed drastic improvements in acute psychotic symptoms and general psychopathology.
“In my opinion, the company doesn’t need to do another study. They have two positive trials, they were both similarly designed, and the phase 2b study had all the features of a phase 3 trial, and I think the uniqueness of this medication with its very low side effect profile makes the drug attractive not only for schizophrenia but for other indications, including bipolar depression and behavioral disturbances in the elderly with dementia, that the company is interested in pursuing as well,” said Dr. Correll.