Push back against schizophrenia with a proven treatment
LYBALVI combines olanzapine, a proven antipsychotic, with another active ingredient, samidorphan.
In a clinical study, LYBALVI reduced the symptoms of schizophrenia in adults when compared with placebo (a pill that contains no medicine).
The effectiveness of LYBALVI was measured in a clinical study using standard surveys. One survey, the Positive and Negative Syndrome Scale (PANSS), was used to measure and assess the severity of symptoms in schizophrenia.Symptoms measured by PANSS
Less weight gain than with olanzapine
In a study of adults living with schizophrenia, patients gained less weight with LYBALVI than with olanzapine*
At 24 weeks in the study, adults who received LYBALVI gained one-third less weight on average than adults who received olanzapine.
- LYBALVI patients gained just over 4% of their weight and olanzapine patients gained almost 7% of their weight
- 18% of LYBALVI patients gained 10% or more of their body weight, while 30% of olanzapine patients gained 10% or more of their body weight
* The effect of LYBALVI on body weight was studied in a 24-week study that included 538 patients with schizophrenia. 266 patients received LYBALVI and 272 patients received olanzapine. Patients with diabetes mellitus were excluded. 36% of patients receiving either LYBALVI or olanzapine stopped taking the study drug before the end of the study. Because patients taking olanzapine were not specifically studied, the weight effect of switching from olanzapine to LYBALVI is unknown.
Percent weight gained
at 24 weeks
Percentage of people who gained 10%
or more of their body weight at 24 weeks
In this study, weight gain was reported as a side effect in 25% of patients taking LYBALVI and 36% of patients taking olanzapine.
In a separate 4-week study of people with schizophrenia that studied LYBALVI and placebo (sugar pill):
19% of patients taking LYBALVI reported weight gain as a side effect compared to 3% of patients taking placebo
- LYBALVI patients gained an average of about 7 pounds, while placebo patients gained an average of about a half a pound
- 26% of patients treated with LYBALVI and 5% of patients treated with placebo gained 7% or more of body weight
LYBALVI may cause serious side effects, including problems with your metabolism, such as high blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who take LYBALVI. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start receiving LYBALVI and during your treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with LYBALVI: feel very thirsty, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick to your stomach, feel confused, or your breath smells fruity.
LYBALVI may also cause increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start and regularly during treatment with LYBALVI. You and your healthcare provider should check your weight regularly.
The most common side effects of LYBALVI when used to treat people with schizophrenia include:
- weight gain
- dry mouth
What's next?Starting LYBALVI