Olanzapine plus samidorphan (Lybalvi) vs olanzapine alone is associated with less weight gain while achieving similar clinical outcomes in patients with recent-onset severe mental illness, new research suggests. However, at least one expert says the weight difference between the two drugs is of "questionable clinical benefit."
Last year, the US Food and Drug Administration (FDA) approved the drug for the treatment of adults with schizophrenia or bipolar I disorder, as a maintenance monotherapy or as either monotherapy or an adjunct to lithium or valproate for acute manic or mixed episodes.
In the ENLIGHTEN-Early trial, researchers examined weight-gain profiles of more than 400 patients with early schizophrenia, schizophreniform disorder, or bipolar I disorder.
Results showed those given combination treatment gained just over half the amount of weight as those given monotherapy. They were also 36% less likely to gain at least 10% of their body weight during the 12-week treatment period.
These findings add to those from the earlier ENGLIGHTEN-2 trial, which included patients with a more established disorder, said lead investigator René S. Kahn, MD, PhD, Icahn School of Medicine at Mount Sinai, New York City.
They indicate that the weight-mitigating effects shown with olanzapine plus samidorphan are "consistent, regardless of the stage of illness," Kahn added.
