The FDA requested additional, long-term clinical trial data from Intra-Cellular Therapies, regarding its investigational lumateperone treatment for schizophrenia.
The FDA has not raised any safety concerns over short-term clinical trials, including six-week Phase III studies in bipolar depression and dementia. Approximately 1,500 patients have been exposed to lumateperone during its development, demonstrating a safety profile similar to placebo, the company said.
The company revealed positive topline results from a Phase III lumateperone trial last September.
Intra-Cellular exclusively licensed lumateperone, also known as ITI-007, from Bristol-Myers Squibb in 2005. The company is preparing responses to the agency’s request for additional information and plans to proceed with the long-term study in schizophrenia, with the goal of submitting an NDA in mid-2018.