“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 Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “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.”
About roluperidone
Roluperidone has been shown to block serotonin, sigma and α-adrenergic receptors that are all involved in the
regulation of important brain functions, including mood, cognition, sleep, and anxiety.
Roluperidone was designed to avoid a direct blockade of
dopaminergic receptors (the key pharmacological target for first- and second-generation antipsychotics), while maintaining blockade of a specific subtype of serotonin receptor called 5-HT2A (an additional key target of second-generation antipsychotics) as well as additional pharmacological targets (sigma2 and
adrenergic-α1A).
About Schizophrenia and Negative Symptoms
Schizophrenia is a chronic, severe, and debilitating type of mental illness characterized by distortions in thinking, perception, emotions, language, sense of
self and behavior. Schizophrenia affects 20 million people worldwide. (World Health Organization).
Negative symptoms can cause individuals
with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure. Negative symptoms are characterized by five constructs: blunted affect, alogia, avolition, anhedonia, and asociality (Marder and
Galderisi, 2017).
Negative symptoms are the main cause of the poor functional outcome of patients suffering from schizophrenia (Harvey et al.,
2020) and may also be one of the main reasons ultra-high risk adolescents may develop full blown schizophrenia (Gomes and Grace, 2017). There are currently no treatments approved for negative symptoms of schizophrenia in the US.
Minerva believes that research continues to emerge indicating that there is a large subgroup of patients with schizophrenia who have moderate to severe
primary negative symptoms and minimal positive symptoms (Galderisi 2021) and have a low risk of worsening of positive symptoms even in the absence of antipsychotic treatments (Harrow 2013;
Moilanen 2016; Murray 2016; Wils 2017; Wunderink 2013; Landolt 2016).