Minerva receives complete response letter from FDA for NDA for roluperidone

Minerva Neurosciences announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, to the Company’s New Drug Application, NDA, for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies: Although one study demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness. The NDA submission lacks data on concomitant antipsychotic administration. 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 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. Minerva must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.