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Also known as Samidorphan IV, Samidorphan (Low Dose)
Samidorphan · 2 trials · 2 indications
EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization (includes psychiatric\& treatment of alcohol intoxication/withdrawal) 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
| Arm | Type | Description |
|---|---|---|
| Samidorphan + olanzapine (ALKS 3831) | EXPERIMENTAL | Active study drug |
| Placebo + olanzapine | PLACEBO_COMPARATOR | - |
| Low Dose | EXPERIMENTAL | Olanzapine + low dose samidorphan tablets taken once daily |
| Medium Dose | EXPERIMENTAL | Olanzapine + medium dose samidorphan tablets taken once daily |
| High Dose | EXPERIMENTAL | Olanzapine + high dose samidorphan tablets taken once daily |
| Placebo | PLACEBO_COMPARATOR | Olanzapine + placebo tablets taken once daily |
| Name | Type | Description |
|---|---|---|
| Samidorphan + olanzapine (ALKS 3831) | DRUG | Oral tablet, taken once daily |
| Placebo + olanzapine | DRUG | Oral tablet, taken once daily |
| Samidorphan (Low Dose) | DRUG | Tablets taken once daily |
| Samidorphan (Medium Dose) | DRUG | Tablets taken once daily |
| Samidorphan (High Dose) | DRUG | Tablets taken once daily |
| Placebo | DRUG | Tablets taken once daily |
| Olanzapine | DRUG | Tablets taken once daily |
Inclusion Criteria: * Has a BMI between 18.0 and 40.0 kg/m2, inclusive * Has a diagnosis of schizophrenia * Has a diagnosis of alcohol use disorder (AUD) * Has experienced an acute exacerbation of schizophrenia within the past 6 months * Additional criteria may apply Exclusion Criteria: * Is preg...
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Samidorphan is an investigational small molecule developed by Alkermes plc (ticker: ALKS) for schizophrenia. It is a partial agonist at the opioid receptors OPRD1, OPRK1, and OPRM1. Samidorphan has completed Phase 2 clinical trials and is not yet approved for any indication.
Samidorphan is being studied for the treatment of schizophrenia. It has been evaluated in completed Phase 2 trials, including one in patients with schizophrenia and alcohol use disorder. It remains investigational and is not approved for schizophrenia or any other condition.
Samidorphan targets the opioid receptors OPRD1 (delta), OPRK1 (kappa), and OPRM1 (mu). It acts as a partial agonist at these receptors. This mechanism is being investigated in schizophrenia, though the drug is still in clinical development.
Samidorphan is being developed by Alkermes plc, which trades under the ticker ALKS. Alkermes has conducted Phase 2 clinical trials of samidorphan, including a combination with olanzapine known as ALKS 3831.
Samidorphan is in Phase 2 of clinical development. Two Phase 2 trials have been completed, and no active trials are currently listed. It is an investigational drug and has not received FDA approval.
Samidorphan has been studied in two completed Phase 2 trials: NCT02161718 in schizophrenia and alcohol use disorder, and NCT01903837 in adults with schizophrenia. Both were randomized, double-blind, placebo-controlled trials conducted in multiple countries.
ALKS 3831 is a combination of samidorphan and olanzapine. Samidorphan is also known as samidorphan IV or samidorphan (low dose). The combination has been studied in Phase 2 trials for schizophrenia.