BURLINGTON, Mass. – Minerva Neurosciences, Inc. (NASDAQ:NERV) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for roluperidone, a treatment for negative symptoms of schizophrenia.
The FDA's letter outlined several clinical deficiencies, including the need for additional studies to establish the drug's effectiveness and long-term safety.
The FDA's feedback indicated that while one study showed statistical significance in the primary efficacy endpoint, it alone was not enough to demonstrate substantial evidence of effectiveness. The regulatory body also highlighted the absence of data on the co-administration with antipsychotic medications and the need for evidence that the change in negative symptoms with roluperidone is clinically meaningful.
Minerva is required to provide further data to support the safety and efficacy of roluperidone, particularly when used alongside other antipsychotic treatments, and to confirm that the observed effect on negative symptoms corresponds to a clinically significant change. Additionally, the FDA called for more information to ensure the long-term safety of the proposed 64 mg dose.
Dr. Remy Luthringer, Executive Chairman and CEO of Minerva, expressed disappointment with the FDA's decision not to approve roluperidone, emphasizing the critical need for treatments addressing the negative symptoms of schizophrenia. The company plans to request a meeting with the FDA to discuss the issues raised in the CRL and to review potential paths forward, which may include conducting additional studies and providing the requested data.
Roluperidone is designed to target specific brain functions by blocking serotonin, sigma, and α-adrenergic receptors without directly inhibiting dopaminergic receptors. Negative symptoms in schizophrenia, such as social withdrawal and lack of motivation or pleasure, significantly impact patients' functional outcomes.
Currently, there are no approved treatments in the U.S. specifically for negative symptoms of schizophrenia, which affect 20 million people worldwide. Minerva believes that there is a significant subset of patients with schizophrenia who primarily exhibit negative symptoms and may not require standard antipsychotic treatments.
This report is based on a press release statement from Minerva Neurosciences.
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