Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
- The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
- The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.
- To address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms.
- “There is a critical need for a treatment for the negative symptoms of schizophrenia.