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Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, and Planned Commercial Formulations of Roluperidone for Treatment of Negative Symptoms of Schizophrenia
Company to Request Pre-NDA Meeting with U.S. Food and Drug AdministrationWALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc.
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Company to Request Pre-NDA Meeting with U.S. Food and Drug AdministrationWALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced results from a pivotal bioequivalence study comparing the roluperidone formulations used in its late-stage Phase 2b and Phase 3 trials, and the planned commercial formulation. The study met all key pharmacokinetic (PK) objectives and the data demonstrate bioequivalence across the various formulations. “The results demonstrate bioequivalence in terms of exposure between the formulations used in our two late-stage Phase 2b and Phase 3 efficacy and safety trials with roluperidone and we believe that the data address certain FDA observations following the Company’s Type C meeting in November 2020,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “These results represent important progress along Minerva’s critical path toward submission of an NDA for roluperidone for the treatment of negative symptoms of schizophrenia, for which there are currently no approved treatment options in the United States.” The area under the curve to last detectable concentration (AUClast), the area under the curve extrapolated to infinity (AUCinf), and the maximum plasma concentration (Cmax) are the most commonly used plasma pharmacokinetic parameters to evaluate bioequivalence between various formulations. For roluperidone, efficacy is mostly driven by plasma exposure of the drug (i.e., AUCs) whereas safety margins improve by reducing Cmax of the drug. Furthermore, as roluperidone is intended for chronic use and the assessed formulations are controlled release, AUCinf is the most relevant of the AUCs when single dose data are collected and used for determining bioequivalence. In this study, the two most important objectives were to establish: The comparability under fasted condition of the 64 milligram (mg) tablet of the Phase 3 formulation of roluperidone compared to the 64 mg dose based on the administration of two 32 mg tablets of roluperidone used in the Phase 2b study, andThe comparability under fasted condition of a 64 mg tablet of the planned commercial formulation of roluperidone compared to the 64 mg dose...