NSFS

Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

Retrieved on: 
Monday, August 22, 2022
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The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.

Key Points: 
  • The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.
  • The NDA submission is supported by results from two late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia (Studies MIN-101C03 and MIN-101C07).
  • Both studies were planned to constitute the bulk of evidence of roluperidones effectiveness for the indication of treating negative symptoms of schizophrenia.
  • Results of Study MIN-101C03 supported the primary hypothesis that after 12 weeks of treatment, roluperidone is superior to placebo in reducing negative symptoms of schizophrenia.

Minerva Neurosciences Announces Publication of Roluperidone Phase 3 Study Results in Schizophrenia Bulletin

Retrieved on: 
Monday, February 28, 2022
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The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning.

Key Points: 
  • The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning.
  • The Company previously disclosed results of the Phase 3 trial of roluperidone in May 2020 and open-label results in May 2021.
  • The Phase 3 study included 513 patients with schizophrenia with moderate to severe negative symptoms.
  • Study patients were administered either 32 mg/day of roluperidone, 64 mg/day of roluperidone, or placebo for 12 weeks.