Minerva Neurosciences receiving a refusal to file letter from the Food and Drug Administration (FDA) regarding its new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia is yet another obstacle to roluperidone’s development, says GlobalData, a leading data and analytics company.

According to GlobalData’s report, ‘Schizophrenia Market Size and Trend Report including Epidemiology and Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021-2031’, prior to this news, it was assumed that roluperidone would launch in Q3 2023 in the US and generate $70.3 million in sales by 2031.

Christie Wong, Pharma Analyst at GlobalData comments: “The refusal to file letter follows two FDA Type C meetings in November 2020 and March 2022. In the most recent Type C meeting, the FDA voiced concerns regarding roluperidone’s failure to meet the primary efficacy endpoint in one of its two pivotal trials, specifically the one conducted in the US. Although the reasoning behind the FDA’s refusal to file letter has not been disclosed, it’s possible the agency still has some unaddressed concerns.”

In addition to this recent regulatory snag, GlobalData believes that more hurdles lie ahead for roluperidone. While key opinion leaders (KOLs) previously interviewed by GlobalData agreed that the schizophrenia market lacked novel treatments to target the negative symptoms of the disease, they were concerned about the limited number of patients suitable for roluperidone treatment. GlobalData estimates that roluperidone will reach a peak patient share of 0.3%, or around 5,400 patients, in the US.

Wong adds: “Roluperidone is being investigated as a monotherapy and concurrent use of roluperidone with an antipsychotic drug has not yet been evaluated. This means that the only patients eligible for roluperidone treatment will be adults who exhibit stable positive symptoms and minimal agitation, without antipsychotic use. KOLs believed this would constitute only a small proportion of the greater schizophrenia population.”

A further competitive threat to the future of roluperidone is Acadia Pharmaceutical’s Nuplazid (pimavanserin tartrate), which is being developed as an adjunctive therapy to atypical antipsychotics to target the negative symptoms of schizophrenia and is anticipated to launch in the US in Q4 2025.

Wong notes: “Unlike roluperidone, Nuplazid can be used in conjunction with antipsychotic therapies either long-term or during relapses, when positive symptoms of schizophrenia return. As such, if approved and launched, Nuplazid will likely compete with roluperidone for patient share and may have a larger target patient population.”

GlobalData forecasts that Nuplazid will generate $216.8 million in sales in the US by 2031.

Wong concludes: “Should roluperidone be able to maneuver past the FDA’s refusal to file letter and eventually receive regulatory approval, Minerva needs to provide strong efficacy data, both as a monotherapy and adjunctive therapy, and solid marketing to set it apart from Nuplazid.”