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Minerva Neurosciences Receives Complete Response Letter From FDA For New Drug Application For Roluperidone For Treatment Of Negative Symptoms In Patients With Schizophrenia Due To Clinical Deficiencies

Author: Benzinga Newsdesk | February 27, 2024 09:09am

In the CRL, the FDA cited the following clinical deficiencies:

Although one study (MIN-101C03) 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 (64 mg) for at least 12 months.

Posted In: NERV