Minerva Announces Outcome Of Meeting With FDA On Development Of Roluperidone

(RTTNews) - Minerva Neurosciences Inc.(NERV) disclosed in a regulatory filing that it has received official meeting minutes from the November 10 Type C meeting with the U.S. Food and Drug Administration regarding development of roluperidone for treatment of negative symptoms in schizophrenia.

The company noted that the objective of the meeting was to obtain FDA input regarding the roluperidone data package and its readiness to support a New Drug Application or NDA submission.

Minerva said it requested confirmation from FDA that the data from the MIN-101C03 (Phase 2b) and MIN-101C07 (Phase 3) studies constitute substantial evidence of the effectiveness of the 64 milligrams dose of roluperidone for the treatment of negative symptoms in schizophrenia and would warrant review of an NDA submission.

According to the company, the FDA advised that the Phase 2b study is problematic because it did not use the commercial formulation of roluperidone and was conducted solely outside of the United States.

The FDA also commented that the Phase 3 study does not appear to be capable of supporting substantial evidence of effectiveness, because neither dose of roluperidone showed a statistically significant separation from placebo at Week 12 in the intent-to-treat or ITT analysis set.

The FDA warned that an NDA submission based on the current data from the Phase 2b and Phase 3 studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication.

The FDA advised that their consideration of both the mITT and ITT results would be a matter of review and that in principle all sites should be included in the primary analysis set, and FDA cannot determine at this time whether data from the referenced site should be removed without a thorough evaluation.

The FDA indicated that Minerva should include justification for exclusion of these data in the future NDA package and provide primary results both with and without these data.

Upon completion of the open label extension of the Phase 3 study, the company expects to request a pre-NDA meeting with FDA to discuss the NDA submission plans based on the clinical efficacy and safety data.