New Real-World Evidence for Olanzapine/Samidorphan and Aripiprazole Lauroxil

Randomized controlled trials remain the gold standard for assessing efficacy and safety, but they do not show how patients responded to a medication in generalized settings, highlighted Panchmatia. Real-world patients often take multiple medications for multiple comorbidities and differ in characteristics from trial participants, so confirming that clinical study findings hold in practice is important, she said.

Panchmatia and McGrory presented on real-world analysis of acute care events evaluated olanzapine/samidorphan (Lybalvi) in patients with schizophrenia or bipolar I disorder and comorbid alcohol use disorder, a common comorbidity in both conditions. Samidorphan, an opioid antagonist, previously reduced drinking days significantly in a clinical trial of patients with alcohol use disorder. Earlier real-world analyses of olanzapine/samidorphan also showed significant reductions in inpatient admissions and emergency department visits.¹ The new analysis addressed whether those reductions held in a high-risk population with multiple comorbidities. "In our prior real world analyses of Lybalvi we have seen significant reductions in these types of acute care events, specifically looking at inpatient admissions or visits to the emergency department," Panchmatia said.

A second poster summarized study data for aripiprazole lauroxil (Aristada), administered once monthly, every 6 weeks, or every 2 months in patients with schizophrenia. The prodrug formulation provided consistent, predictable plasma concentrations that avoided the partial adherence seen with oral aripiprazole and enhanced efficacy over the oral formulation.² "Aristada's prodrug formulation is really key to being able to provide consistent and predictable plasma concentrations over the entire interval for the patients being treated with Aristada, whether that be a month, 6 weeks or 2 months," McGrory said. Peak-to-trough ratio—the maximal drug concentration relative to the lowest—was a pharmacokinetic parameter many clinicians did not consider, and a smaller difference may improve an individual patient's treatment experience.

The established safety and tolerability profile of aripiprazole, including potentially less sedation, weight gain, and metabolic dysfunction, carried over to the long-acting injectable. Because the medication was delivered for up to 2 months, a clearly established safety profile mattered to clinicians and patients. Safety data across several clinical trials matched oral aripiprazole, with no additional risk from the long-acting injectable formulation.²

Dr McGrory is medical strategy lead for psychiatry and senior medical director & product lead at Alkermes.

Ms Panchmatia is senior director and head of psychiatry HEOR at Alkermes.

References

1. Jain R, Penn A, Carbray J, et al. Acute care events following initiation of olanzapine/samidorphan among patients with schizophrenia or bipolar 1 disorder and comorbid alcohol use disorder. Poster presented at: Psych Congress 2026 Annual Meeting; September 15-19; New Orleans, LA. Accessed September 18, 2026.

2. Kempf B, Carbray J, Barbee R, et al. Use of an aripiprazole lauroxil injection administered once every month, 6 weeks, or 2 months in people with schizophrenia: a clinician focused summary of study data. Poster presented at: Psych Congress 2026 Annual Meeting; September 15-19; New Orleans, LA. Accessed September 18, 2026.