FDA calls off AdComm for Intra-Cellular's schizophrenia prospect

FDA Building 2
The FDA canceled the advisory committee meeting "because of new information regarding the application" but did not specify what that information was. (FDA)

Intra-Cellular Therapies’ lead asset hit a snag Tuesday afternoon as the FDA canceled an advisory panel meeting scheduled for next Wednesday. The company is developing lumateperone as an oral med for schizophrenia. 

“This meeting has been cancelled because of new information regarding the application,” the agency said in an update. It did not specify what this information was. Intra-Cellular's stock dived 30% on the news. 

“The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register,” the FDA said. It is scheduled to make a decision to approve lumateperone by Sept. 27. 

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ICT is seeking approval for the treatment of schizophrenia in adults but is also developing lumateperone for other neuropsychiatric disorders such as bipolar disorder, major depressive disorder and behavioral disturbances stemming from dementia. 

The drug is a dopamine receptor phosphoprotein modulator that targets three neurotransmitter pathways that play a role in these diseases—serotonin, dopamine and glutamate. The company believes this profile sets it apart from other antipsychotic drugs and could boost its effects on the negative symptoms of schizophrenia, such as social withdrawal. 

The New York-based company raised $150 million in late 2017 to bankroll lumateperone’s journey toward its FDA filing as well advance its other programs. And earlier this month, ICT unveiled a mixed bag of data from two phase 3 trials testing the drug in bipolar disorder. 

In one study, lumateperone beat placebo at reducing scores that measure the severity of depression and bipolar disorder. But in the second study, the drug did not separate from placebo, though the company put it down to a high placebo response.

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