FDA Advisory Committee Cancels Review of Intra-Cellular’s Schizophrenia Drug

Shares of Intra-Cellular Therapies plunged Tuesday afternoon after the company announced the U.S. Food and Drug Administration (FDA) canceled the advisory committee meeting to discuss the company’s New Drug Application for its schizophrenia drug, lumateperone.

The FDA’s Psychopharmacologic Drugs Advisory Committee meeting was scheduled for July 31. The committee meeting was canceled due to additional non-clinical study information provided by the company to the FDA, the company said Tuesday afternoon. In its brief announcement, Intra-Cellular said the advisory meeting was terminated in order to “allow sufficient time to review this new and any forthcoming information as they continue the NDA review.”

Intra-Cellular’s lumateperone provides selective and simultaneous modulation of serotonin, dopamine, and glutamate, which are three neurotransmitter pathways implicated in severe mental illness. Intra-Cellular submitted its New Drug Application to the FDA last year, the first NDA for the company. In 2017 the FDA granted Fast Track designation for lumateperone. When the Phase III results were released, the data was mixed, with one trial hitting the mark and the other falling short.

Intra-Cellular noted that the additional information provided could result in the company not seeing approval of lumateperone by the Sept. 27 PDUFA data. The company has a meeting scheduled with the FDA and will provide an update following the meeting. In a brief statement, the FDA said it intends to continue evaluating the application and will announce future meeting dates if needed.

At the time the FDA accepted the New Drug Application, Sharon Mates, chairman and chief executive officer of Intra-Cellular, said there are still significant unmet medical need in treating schizophrenia. Mates added that the company welcomed the opportunity to present the company’s data to the advisory committee for potential approval. Schizophrenia affects about 1% of the world’s population. Many of the treatments available do not provide broad symptom control across other symptom domains, Intra-Cellular noted.

Earlier this month, Intra-Cellular released Phase III data from two clinical trials evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. The trials were a mixed bag of results for lumateperone. In one trial, lumateperone met its primary endpoint for improvement in depression, as well as a key secondary endpoint. However, in another of the Phase III trials, neither dose of lumateperone met the primary endpoint of statistical separation from placebo, the company said.

It is unknown if the data from these Phase III trials played any role in the advisory committee canceling its session later this month or if the data from the trials were part of the information that Intra-Cellular provided to the FDA.

Intra-Cellular isn’t the only company to see a stumble related to schizophrenia this week. San Diego-based Acadia’s Nuplazid failed to hit endpoints in a Phase III trial. On Monday, the company said patients receiving Nuplazid showed a consistent trend in symptom improvement but did not hit statistical significance on the primary endpoint.