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.

Posted In: BriefsPhase 2 TrialPhase 3 TrialSchizophreniaBiotechNewsPenny StocksHealth CareMoversTrading IdeasGeneral

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