Minerva Posts Positive Bioequivalence Results For Schizophrenia Candidate Formulations

Minerva Neurosciences Inc NERV announced results from a bioequivalence study comparing roluperidone formulations used in Phase 2b and Phase 3 trials and the planned commercial formulation.
Related Link: Minerva's Schizophrenia Candidate Shows Long Term Improvement In Negative Symptoms, Functioning
The 48-subject study met all key pharmacokinetic (PK) objectives, and the data demonstrate bioequivalence across the various formulations.
The data showed comparability under the fasted condition of the 64 milligram (mg) tablet of Phase 3 trial & planned commercial formulation of roluperidone compared to two 32 mg tablets in the Phase 2b study.
The AUCinf were bioequivalent, and Cmax of the reformulated phase 3 and planned commercial formulations were reduced substantially compared to the Phase 2b formulation.
Price Action: NERV stock is down 2.82% at $1.72 on the last check Thursday.