Minerva's expected release of the schizophrenia treatment roluperidone encounters a significant hurdle as the FDA's denial poses the potential for a delay of at least two years.
Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
Go to source) 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.
Schizophrenia
Schizophrenia is a mental disorder characterized by symptoms of thought, behavior and social problems.
Schizophrenia is a mental disorder characterized by symptoms of thought, behavior and social problems.
‘The anticipated launch of Minerva's schizophrenia treatment, roluperidone, faces a substantial setback with the FDA's denial, potentially causing a delay of at least two years. #schizophrenia #FDA’
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.
Reference:
- Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia - (https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-receives-complete-response-letter-fda-new)
Quiz on Schizophrenia
Schizophrenia is a mental disorder that affects young adults; nearly 7% of the adult population is affected by this condition. Check out how much you know about schizophrenia by taking this quiz. ...
Schizophrenia is a mental disorder that affects young adults; nearly 7% of the adult population is affected by this condition. Check out how much you know about schizophrenia by taking this quiz. ...
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