Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Samidorphan+ olanzapine · 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...
Samidorphan is an investigational small molecule being studied in schizophrenia and alcohol use disorder. It is also being evaluated in healthy volunteers for abuse liability and drug metabolism studies. The drug is not approved and remains in clinical development.
Samidorphan is being developed by Alkermes plc, a biopharmaceutical company traded on NASDAQ under the ticker ALKS. The company is conducting clinical trials of the drug in schizophrenia and related conditions.
Samidorphan is in Phase 1 clinical development. While some completed trials were Phase 2, the most recent and ongoing development stage is Phase 1. The drug is investigational and has not been approved by regulatory authorities.
Samidorphan has been studied in several completed trials, including NCT01903837 in schizophrenia, NCT02161718 in schizophrenia with alcohol use disorder, NCT02218021 in healthy recreational opioid users, and NCT02504463 in healthy male volunteers. All trials are completed.
Samidorphan is also known as ALKS 33. In clinical trials, it has been studied under the name ALKS 3831, which appears to be a combination or formulation of the drug. The trials NCT01903837 and NCT02161718 used the ALKS 3831 designation.