ITI-007 Phase 3 Results

This is the second phase 3 clinical trial for patients with schizophrenia and Intra-Cellular drug ITI-007.  This trial had Risperidone as an active comparator and a placebo arm, the clinical trial is here NCT02469155.  I am including our write up on the first phase 3 clinical trial (Study '301) here ITI-007 Phase 3 Results, for the specific reason of attempting to uncover how ITI-007 has performed on the PANSS Negative Symptoms subscale.  The first phase 3 clinical trial did not show statistically significant improvement in the PANSS Negative Symptoms subscale from the company PR in September of 2015. Below are the results for the ITI-302 phase 3 study.

• 60 mg -14.6
• 20 mg -15.0
• Risperidone 4mg -20.1
• Placebo -15.1

Today (Study '302) the company released phase 3 clinical trial top line results, that did not mention any significance to the Negative Symptoms in the Intra-Cellular press release. Intra-Cellular's ITI-007 results today should create some skepticism regarding the drug as a viable CNS candidate for Schizophrenia as Risperidone outperformed ITI-007.  The PANSS Negative Symptom subscale had zero mention from today's top-line press release. Based on the two phase 3 clinical trials, ITI-007 does not have a strong effect on the PANSS Negative Symptoms subscale.  AVP-786 is currently in clinical trials being tested for negative symptoms associated with schizophrenia.  Thank you for reading.