Conclusion: Though ulotaront offers an improved safety/tolerability profile over the generic antipsychotic risperidone for patients with schizophrenia, its likely price would consign it to later-line use if approved.
Antipsychotics such as risperidone, olanzapine, and quetiapine provide efficacy for patients with schizophrenia, but come with substantial safety/tolerability baggage. However, Ulotaront (Sunovion), an antipsychotic in phase 3 clinical trials, may reduce unmet need by providing efficacy comparable to current therapies with fewer tolerability issues.
We modeled risperidone as the standard of care, as it gave the lowest unmet need score in our framework. Efficacy values on the Positive and Negative Syndrome Scale (PANSS) in our analysis are from short-term trials, but efficacy may differ in long-term settings and uncontrolled patient populations.
While ulotaront did not reduce PANSS scores as much as risperidone did, it had a lower discontinuation rate, giving it a slight edge over risperidone in efficacy. Ulotaront appears to provide acceptable efficacy with improved tolerability over the commonly used atypical antipsychotics.
However, we expect ulotaront’s cost will limit its share. We projected its annual wholesale acquisition cost (WAC) at about $17,000, equal to that of Lybalvi (olanzapine/samidorphan, Alkermes), a schizophrenia drug with a similar therapeutic profile that entered the US market in late 2021. Generic risperidone’s yearly cost is about $130. The assumed price diminishes ulotaront’s clinical innovation by -6.9%. The result is overall minimal clinical innovation of 1.8%. History shows that new drugs need to hit 5% clinical innovation to have good commercial prospects.
If we compare ulotaront with Lybalvi, ulotaront has 2.7% clinical innovation over Lybalvi, based on a slightly better side effect profile and marginally better efficacy.
We predict that ulotaront will occupy a niche similar to Lybalvi’s. Both drugs have efficacy like the second-generation antipsychotics, a high price penalty, and notably improved safety and tolerability. Generics will remain the top first-line choice owing to price. However, even with low clinical innovation compared to risperidone, we expect ulotaront and Lybalvi will be important for patients who fail or cannot tolerate generic antipsychotics.
Lybalvi’s team is already thinking about competing against generics, expecting that the frequent drug-switching (usually driven by adverse events) seen in schizophrenia will get their drug tested in many patients. Sunovion will likely adopt a similar strategy with ulotaront.