On February 27, Minerva Neurosciences announced that it received a complete response letter (CRL) from the FDA regarding the company’s new drug application (NDA) for roluperidone for the treatment of negative symptoms associated with schizophrenia. The CRL requested additional efficacy and safety data, which could delay the potential launch of roluperidone for at least two years.

Schizophrenia is a heterogeneous behavioural and cognitive syndrome involving chronic or recurrent psychosis. The disorder is characterised by positive symptoms, negative symptoms, and cognitive deficits. The current schizophrenia treatment landscape includes many established atypical antipsychotic products that can help manage the positive symptoms of schizophrenia such as hallucinations, delusions, and disorganized speech. However, some patients still experience negative symptoms of the disorder including avolition, social withdrawal, and flat emotional affect. Key opinion leaders (KOLs) previously interviewed by GlobalData agreed that the negative symptoms of schizophrenia have a major impact on the patient’s quality of life and that there is a need for novel treatment options to target the negative symptoms of schizophrenia.

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Minerva’s CRL follows a refusal to file in October 2022 and two FDA Type C meetings in November 2020 and March 2022. Although roluperidone met its primary endpoint in a Phase IIb randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of roluperidone in patients with negative symptoms of schizophrenia (EudraCT-2014-004878-42), the FDA cited that additional efficacy was required to support its approval. Roluperidone previously failed to reach its primary endpoint in a Phase III study (Eudra-CT: 2017-003333-29; NCT03397134). To manoeuvre past the clinical deficiencies stated in the recent CRL, Minerva must provide additional safety and efficacy data for roluperidone, including data to support concomitant antipsychotic usage. According to GlobalData’s Feasibility Planner and Benchmark model, a Phase III clinical trial that investigates the safety and efficacy of a drug intervention for the treatment of schizophrenia has an expected trial duration of almost 23 months. In addition, the FDA provided comments on clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues, among other items. To address the comments raised by the FDA will delay the potential launch of roluperidone, where the launch of other late-stage pipeline products is anticipated.

In addition to the regulatory snag, roluperidone will need to compete with Acadia Pharmaceuticals’s Nuplazid (pimavanserin tartrate), in Phase III development as an adjunctive therapy to atypical antipsychotics to target the negative symptoms of schizophrenia. The top-line results for the Phase III trial (ADVANCE-2, NCT04531982) are expected next month. GlobalData forecasts the launch of Nuplazid for the treatment of negative symptoms of schizophrenia in the US by Q4 2025.

However, should these products that target only the negative symptoms of schizophrenia receive regulatory approval, they may face restricted reimbursement in the US. Payers previously interviewed by GlobalData noted that while these products may improve the quality of life of patients by improving negative symptoms, they may not have a direct impact on cost offsets such as hospitalizations. As such, pricing and reimbursement may limit the potential of products that only target negative symptoms to gain market share.

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