Real-World Evidence and Long-Term Data for Lybalvi and Aristada

Retrospective claims analysis data showed significant reductions in hospital and emergency department visits after initiation of Lybalvi (olanzapine/samidorphan) among patients with schizophrenia or bipolar I disorder and comorbid alcohol use disorder (AUD), according to Hemangi Panchmatia, MS. Acute care events were measured in 4 categories: all-cause, mental health–related, disease-related, and AUD-related. "We saw a significant reduction across all of these 4 categories in our schizophrenia patients as well as bipolar I disorder patients who have a comorbid alcohol use disorder," Panchmatia said.

Samidorphan, an opioid antagonist with strong binding at the mu receptor, was combined with olanzapine to attenuate weight gain and metabolic dysfunction. Peripheral effects included glucose metabolism and fat accumulation, whereas central effects on the brain's reward system may have supported satiety and reduced cravings. Antecedent studies fed into a long-term open-label extension lasting up to 4 years or beyond for many patients, and mitigation of weight gain and metabolic dysfunction was associated with better adherence and longer persistence.¹ Many patients had no significant weight gain, and metabolic parameters remained stable over a long period. Findings extended across schizophrenia and bipolar I disorder and across patients early in illness and those more typical of clinical trials. "It's important to provide your patients with an efficacious treatment that they can adhere to, that they can tolerate, and that they will stay on for long periods of time," McGrory said.

A separate clinician-focused poster summarized the development program for aripiprazole lauroxil, a long-acting injectable prodrug formulated to reduce absorption. This design allowed extended release with consistent, predictable plasma concentrations and without pronounced peak and trough effects, maintaining patients at levels relevant to their symptoms. Dosing once monthly, every 6 weeks, or every 2 months allowed clinicians to individualize intervals. Significant symptom reductions were observed on the Positive and Negative Syndrome Scale, with improvement on the Clinical Global Impression–Severity scale.² The adverse event profile mirrored that of oral aripiprazole over an extended period, including low sedation and lower levels of metabolic dysfunction and weight gain.

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.