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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 LYBALVI
ALKS 3831 · 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...
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ALKS 3831 is being developed for the treatment of schizophrenia. Clinical trials have also enrolled patients with schizophreniform disorder and bipolar I disorder. It is an investigational small molecule that has not been approved by the FDA and remains in clinical development.
ALKS 3831 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. The company is the sponsor of the clinical program, which includes Phase 3 trials in schizophrenia and related conditions.
ALKS 3831 is in Phase 3 development. Six trials have been completed, including Phase 3 studies, and no trials are currently active. The program has enrolled approximately 2,099 participants across its completed studies.
Completed trials of ALKS 3831 include NCT03201757, a Phase 3 long-term safety and tolerability study; NCT03187769, a Phase 3 efficacy study on body weight in young adults; NCT02873208, a Phase 3 long-term safety study in adults with schizophrenia; and NCT02804568, a Phase 1 safety study.
ALKS 3831 is a small molecule therapeutic. Its molecular target has not been specified in the available program information, so its precise mechanism of action is not described here. It is being studied for schizophrenia and related psychiatric conditions.