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# After FDA Meeting, Minerva Continuing Roluperidone Development
- URL: https://www.fdaweb.com/after-fda-meeting-minerva-continuing-roluperidone-development/
- Published: 2020-12-01T12:00:00.000Z
- Updated: 2026-09-14T16:38:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148198

Minerva Neurosciences says that following a meeting with FDA on the data package and readiness to support an NDA of its roluperidone to treat negative symptoms in schizophrenia, it is continuing its development and NDA activities. Minerva [says](http://www.globenewswire.com/news-release/2020/12/01/2137388/0/en/Minerva-Neurosciences-Announces-Outcome-of-Type-C-Meeting-with-FDA-and-Next-Steps-in-the-Development-of-Roluperidone.html?ref=fdaweb.com) it had asked the agency to confirm that data from a Phase 2b and Phase 3 study constituted substantial evidence of the effectiveness of a 64 mg dose of roluperiodone that would warrant a review of an NDA.

The agency responded that the Phase 2b study is problematic because it did use the commercial formulation of roluperidone and was conducted solely outside the U.S. And it said that the Phase 3 study did not appear capable of supporting substantial evidence of effectiveness because neither dose of the drug showed a statistically significant separation from placebo in the intent-to-treat analysis set.

Minerva says it believes that FDA’s comments can be addressed based on published regulatory guidance and precedents.