Minerva Seeks FDA Approval For Schizophrenia Candidate

Minerva Neurosciences NERV has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone in the treatment of negative symptoms for patients with schizophrenia.

The regulatory submission is supported by results from MIN-101C03 and MIN-101C07, two late-stage studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia.

The results of MIN-101C03 study is supported the primary hypothesis that after 12 weeks of treatment, roluperidone is superior to placebo in reducing negative symptoms of schizophrenia.

The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia.

Minerva is seeking approval for the 64 mg dose of roluperidone.

Remy Luthringer, Executive Chairman and Chief Executive Officer, commented: "We believe that roluperidone may represent a new therapeutic option to treat patients with negative symptoms of schizophrenia for which there are currently no approved therapies in the United States. While positive symptoms of schizophrenia are generally well managed with antipsychotics, negative symptoms are often the main burden of illness and can impact the patients' quality of life as a result of disabilities caused by impaired vocational and social skills.”

The company discussed the development of roluperidone with the regulatory authorities during the Type C meeting held in March, for the treatment of negative symptoms in schizophrenia.

Schizophrenia is a chronic, severe, and debilitating type of mental illness characterized by distortions in thinking, perception, emotions, language, sense of self and behavior.

Price Action : Minerva shares are trading higher at $3.12 on Monday at the time of publication.