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Lybalvi (SAMIDORPHAN)
Lybalvi blocks the action of opioids at their receptor sites in the brain.
Lybalvi, an opioid receptor antagonist developed by Alkermes Inc, is currently marketed for the treatment of schizophrenia. Its key strength lies in its unique mechanism of blocking opioid receptors, which differentiates it from other antipsychotics in the same class. The primary risk to Lybalvi is the strong competition from established generics like olanzapine and quetiapine, as well as the upcoming patent expiry in 2028 for its key composition patent.
At a glance
| Generic name | SAMIDORPHAN |
|---|---|
| Sponsor | Alkermes Inc |
| Drug class | Atypical Antipsychotic [EPC] |
| Target | Mu-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar disorder could be mediated through combination of dopamine and serotonin type (5HT2) antagonism.The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.
Approved indications
- Schizophrenia
- Bipolar I Disorder - Acute Manic or Mixed Episodes
- Bipolar I Disorder - Maintenance Monotherapy
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 )
Common side effects
- weight increased
- somnolence
- dry mouth
- increased appetite
- blood insulin increased
- waist circumference increased
- blood creatine phosphokinase increased
- headache
- lethargy
- sedation
- akathisia
- alanine aminotransferase increased
Key clinical trials
- Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (PHASE3)
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (PHASE3)
- National Pregnancy Registry for Psychiatric Medications
- Exercise and Olanzapine-samidorphan (PHASE4)
- A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia (PHASE3)
- Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (PHASE3)
- Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder (PHASE1)
- Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lybalvi CI brief — competitive landscape report
- Lybalvi updates RSS · CI watch RSS
- Alkermes Inc portfolio CI