FDA says Phase 3 study for roluperidone remains negative; additional data needed

Minerva Neurosciences, Inc.

FDA stated the Phase 3 study is negative under the Hochberg procedure; both 32 mg and 64 mg doses must be significant.
Excluding a site with data integrity issues gave nominal p=0.044 for 64 mg dose, but FDA still deems study negative.
Division raised concerns about monotherapy use, patient identification, and lack of data on coadministration with antipsychotics.
FDA suggested additional data could address concerns; Minerva may begin data collection in parallel with NDA preparations.
Minerva still believes it has two adequate studies and targets NDA submission in summer 2022; webcast April 13.

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