FDA Delays Approval of Roluperidone for Schizophrenia Treatment

Minerva Neurosciences’ roluperidone encounters a setback as the FDA issues a Complete Response Letter, subsequent to a refusal to file in October 2022 and two FDA Type C meetings in November 2020 and March 2022. Addressing clinical deficiencies mandates Minerva to provide additional safety and efficacy data, including support for concomitant antipsychotic usage.

The anticipated duration of a Phase III clinical trial for schizophrenia treatment, according to GlobalData’s Benchmark model, is nearly 23 months, potentially delaying the launch for at least two years, coinciding with the expected introduction of other pipeline product.

Addressing the Ongoing Struggle with Negative Symptoms in Antipsychotic Treatment

Despite the availability of established atypical antipsychotic products addressing positive symptoms, patients still grapple with negative symptoms like avolition, social withdrawal, and flat emotional affect. Key opinion leaders (KOLs) consulted by GlobalData emphasize the significant impact of these negative symptoms on patients’ quality of life, highlighting the need for innovative treatment options.

Did You Know?

The anticipated launch of Minerva’s schizophrenia treatment, roluperidone, faces a substantial setback due to the FDA’s rejection, introducing the possibility of a delay of at least two years.

In addition to the regulatory challenges, roluperidone faces competition from Acadia Pharmaceuticals’ Nuplazid in Phase III development, targeting negative symptoms as an adjunctive therapy to atypical antipsychotics. However, if these products gain regulatory approval, payers foresee potential reimbursement restrictions in the US for treatments solely focusing on negative symptoms.

While such products may enhance patients’ quality of life, improving negative symptoms, they may not directly influence cost offsets like hospitalizations. Consequently, pricing and reimbursement considerations may hinder the market share potential of products exclusively targeting negative symptoms.


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