Nuplazid (Acadia Pharmaceuticals) contains pimavanserin, which is a selective serotonin inverse agonist preferentially targeting the serotonin 5-HT2A receptors. Its novel mechanism of action targets the serotonergic 5-HT2A receptors while avoiding activity at dopamine and other receptors, distinguishing it from other antipsychotics.
Nuplazid is being developed to fulfill a critical unmet need, as it is targeted towards treatment-resistant schizophrenia and negative symptoms. Demonstrating a favorable side-effect profile is vital to Nuplazid’s position as it is being developed as an adjunctive therapy in a treatment landscape where physicians constantly select monotherapies over combination regimens. The preference for monotherapies is driven by treatment guidelines. Given the dubious evidence supporting combination use, the potentially negative compliance, cost, and tolerability implications are considered too weighty to risk for a minor additional benefit in return. Poor tolerability would significantly dampen Nuplazid’s prospects, as this would notably fail to differentiate the product from clozapine (the only currently approved therapy for treatment-resistant schizophrenia). The author believes that demonstrating Nuplazid’s superior clinical profile to clozapine represents a key opportunity for the drug to establish a competitive clinical profile.
List of Figures
Figure 1: Nuplazid for schizophrenia - SWOT analysis
Figure 2: Drug assessment summary of Nuplazid for schizophrenia
Figure 3: Drug assessment summary of Nuplazid for schizophrenia
Figure 4: Nuplazid sales for schizophrenia across the US and five major EU markets, by country, 2017-26
List of Tables
Table 1: Nuplazid drug profile
Table 2: Nuplazid Phase II and Phase III trials in schizophrenia
Table 3: Nuplazid Phase II data in schizophrenia
Table 4: Nuplazid sales for schizophrenia across the US and five major EU markets, by country ($m), 2017-26