Minerva Neurosciences Announces the Results of the Phase 3 Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia

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It’s a pity it failed phase 3 trials.

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So will they continue to test it?

@jamesbond @everhopeful

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:money_with_wings::moneybag::money_with_wings::moneybag::money_with_wings::moneybag: If there’s money to be made.

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It’s not bad but it doesn’t allow for any comparison to placebo or to another med (because the participants were all on Roluperidone.)

  • Continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS) observed over one year (12-week double-blind and 40-week open-label periods) in patients receiving both 64 mg and 32 mg doses
  • Continuous improvement in Personal and Social Performance (PSP) total score over one year, suggesting improvement in patients’ everyday life functioning
  • Favorable safety profile with few serious adverse events and no evidence of somnolence, extrapyramidal side effects or weight gain

Still, it’s probably doing something, because “only” 11% of the people had relapses.

The relapse rate during the OLE (open label extension), defined as patients being withdrawn from the trial due to worsening of symptoms of psychosis, was 15 patients out of 166 patients (9%) in the 32 mg arm and 10 patients out of 167 patients (6%) in the 64 mg arm. Over the one-year duration the relapse rate was 11.7% overall.

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Looks like they’re pressing ahead with trying to get it approved.

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Thanks @everhopeful

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