Minerva Reports Positive Phase 3 Data from Long-Term Study of Schizophrenia Drug Candidate
04:54 PM EDT, 05/11/2021 (MT Newswires) -- Minerva Neurosciences (NERV) reported positive Phase 3 data from a one-year clinical study of its drug candidate roluperidone for the treatment of negative symptoms of schizophrenia.
The company said the results will help support the submission of a new drug application to the FDA following the completion of certain work to address comments made by the agency during a meeting about the product last November.
"I am delighted to announce that our one-year Phase 3 trial, now completed, supports our view that roluperidone, administered without concomitant treatment with antipsychotics, can potentially improve negative symptoms of schizophrenia and social functioning over the long term," said Dr. Remy Luthringer. CEO of Minerva Neurosciences, in a statement.
"We believe the data also suggest that roluperidone's unique pharmacology and mechanism of action potentially help to maintain the stability of psychotic symptoms over the duration of treatment," he added.