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FDA Rejects Minerva’s New Drug Application for Schizophrenia Treatment


Agency identified several clinical deficiencies in the study, including insufficient evidence for roluperidone in the treatment of the negative symptoms associated with schizophrenia.

schizophrenic man - mental disorder. Image Credit: Adobe Stock Images/Andreza

Image Credit: Adobe Stock Images/Andreza

Minerva Neurosciences announced that the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application for roluperidone, its treatment for the negative symptoms associated with schizophrenia. The agency stated that there were several insufficiencies in the trial data, including inadequate evidence of efficacy from a single study, lack of data on concomitant antipsychotic use, inadequacy in demonstrating clinical meaningfulness of symptom changes, and insufficient safety data for the proposed dose over a 12-month period. In order to earn an approval, the FDA stated that Minerva must submit an additional positive study, additional safety, and efficacy data for co-administration with antipsychotics, proof of clinically meaningful symptom change, and long-term safety data for approval.1

“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” said Remy Luthringer, PhD, executive chairman, CEO, Minerva, in a press release. “There is a critical need for a treatment for the negative symptoms of schizophrenia. We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia and we will review FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed, with the goal of bringing this much needed therapy to patients and physicians.”

This isn’t the first time that the treatment was rejected by the FDA. Back in October 2022, the agency sent Minerva a refuse to file letter, with the option to request a Type A meeting aimed to explain why the application was refused.2

“We are disappointed that the FDA has not accepted our NDA for roluperidone. Our goal remains to provide a new and much needed therapeutic option to help patients and their families, since there are currently no approved therapies to treat negative symptoms of schizophrenia in the United States,” said Luthringer, in a prior press release. “The company intends to request a Type A meeting and looks forward to continued discussions with the FDA.”

In late 2021, Minerva reported positive results from its late-stage Phase IIb and Phase III trials of roluperidone. Reportedly, the study met all key pharmacokinetic objectives, with data demonstrating bioequivalence across the various formulations.3

“The results demonstrate bioequivalence in terms of exposure between the formulations used in our two late-stage Phase IIb and Phase III efficacy and safety trials with roluperidone and we believe that the data address certain FDA observations following the Company’s Type C meeting in November 2020,” said Luthringer, regarding the results at the time. “These results represent important progress along Minerva’s critical path toward submission of an NDA for roluperidone for the treatment of negative symptoms of schizophrenia, for which there are currently no approved treatment options in the United States.”


1. Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia. Minerva. February 27, 2024. Accessed February 28, 2024. https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-receives-complete-response-letter-fda-new

2. Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia. Minerva. October 17, 2022. Accessed February 28, 2024. https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-receives-refusal-file-letter-fda-its-new

3. Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, and Planned Commercial Formulations of Roluperidone for Treatment of Negative Symptoms of Schizophrenia. Minerva. September 30, 2021. Accessed February 28, 2024. https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-announces-study-results-demonstrating

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