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Label indication LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in… FDA label
Also known as ALKS 3831
LYBALVI · 7 trials · 5 indications
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
Overall summary of treatment emergent adverse events during the treatment period
| Arm | Type | Description |
|---|---|---|
| ALKS 3831 | EXPERIMENTAL | Coated bilayer tablet |
| Olanzapine | ACTIVE_COMPARATOR | Coated bilayer tablet |
| 5mg OLZAPINE /10mg SAMIDORPHAN | EXPERIMENTAL | Open label, single dose 5mg OLZ/10 mg SAM |
| Group 1 | EXPERIMENTAL | Olanzapine/samidorphan 10 mg/10 mg |
| Group 2 | EXPERIMENTAL | Olanzapine/samidorphan 20 mg/10 mg |
| Name | Type | Description |
|---|---|---|
| ALKS 3831 | DRUG | Olanzapine + samidorphan, daily oral dosing |
| Olanzapine | DRUG | Daily oral dosing |
| LYBALVI | DRUG | 5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder |
Inclusion Criteria: * Willing and able to give informed consent/assent as per local requirements * Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal * Has the potential to benefit f...
LYBALVI is an investigational small molecule developed by Alkermes plc (ticker ALKS). It is being studied in a Phase 1 clinical trial, and its therapeutic area is classified as other. The specific indications for LYBALVI have not been disclosed. It is not yet approved and remains in clinical development.
LYBALVI is made by Alkermes plc, which trades under the ticker ALKS. Alkermes is the developer responsible for the clinical program. The company is conducting a Phase 1 study of LYBALVI in healthy lactating women.
LYBALVI is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The total enrollment across the program is 12 participants. LYBALVI is investigational and has not been approved for any indication.
LYBALVI has been studied in one completed Phase 1 trial, NCT05547100, titled Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan. The trial enrolled 12 healthy lactating women in the United States, with a minimum age of 18 years. It was an uncontrolled study.