Intra-Cellular Therapies said that the FDA cancelled an advisory committee meeting to discuss a marketing application for lumateperone for the treatment of schizophrenia after the company submitted new information requested by the agency. The meeting of the Psychopharmacologic Drugs Advisory Committee was scheduled for July 31.
According to Intra-Cellular, the FDA's requests related to non-clinical studies, adding that the advisory committee meeting was cancelled to give the agency time to review the new information. The regulator had previously asked the company to provide additional information in response to certain findings in animal toxicology studies of lumateperone. The FDA accepted the drugmaker's filing seeking approval of the drug for this indication last December.
Intra-Cellular noted that it has an upcoming meeting with the FDA, although it indicated that the submission of the new information may result in an extension of the September 27 target review date. Shares in the company slipped as much as 31% on the news.
In 2015, Intra-Cellular reported that a Phase III study of lumateperone in patients with schizophrenia met its primary endpoint at the higher dose tested. However, in a second late-stage trial, the serotonin 5-HT2A receptor antagonist failed to separate from placebo at either tested dose, with the company citing an unexpectedly large placebo response.
The cancellation of the FDA advisory committee meeting comes shortly after Intra-Cellular announced that a Phase III study of lumateperone for the treatment of major depressive episodes associated with bipolar disorder failed to hit its main goal due to "a high placebo response." At the same time, Intra-Cellular reported that a second late-stage trial in the same indication achieved its primary endpoint.
For related analysis, see ViewPoints: So we meet again – ITCI, placebo response set to do battle once more, and KOL Views Results: Leading psychiatrist sees regulatory success, commercial challenges ahead for lumateperone.
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