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OLZ/SAM · 3 trials · 2 indications
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
| Arm | Type | Description |
|---|---|---|
| Group 1 OLZ/SAM | EXPERIMENTAL | Fixed dose combination of olanzapine and samidorphan |
| Group 2 Olanzapine | ACTIVE_COMPARATOR | Fixed dose of olanzapine |
| All subjects | EXPERIMENTAL | All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth) |
| Group 1 Olanzapine/ 5 mg Samidorphan | EXPERIMENTAL | Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 5mg (Range: 5-20mg Olanzapine/samidorphan 5mg) |
| Group 2 Olanzapine/ 10mg Samidorphan | EXPERIMENTAL | Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg) |
| Name | Type | Description |
|---|---|---|
| OLZ/SAM | DRUG | OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg. |
| Olanzapine | DRUG | The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day |
Inclusion Criteria: * Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria * Subject is an outpatient or will be able to be treated on an outpatient ...
OLZ/SAM is an investigational small molecule being developed for Bipolar I Disorder and Schizophrenia. It is currently in Phase 3 clinical development and is not yet approved by the FDA. The drug is being studied in pediatric subjects aged 10 years and older.
OLZ/SAM is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric patients with Bipolar I Disorder and Schizophrenia.
OLZ/SAM is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The Phase 3 program includes a long-term safety extension study and a study evaluating weight gain in pediatric subjects with Schizophrenia or Bipolar I Disorder.
OLZ/SAM is being studied in several clinical trials. NCT04987229 is a Phase 3 long-term safety extension study in pediatric subjects. NCT04987658 is a completed Phase 1 study in pediatric subjects with Bipolar I Disorder. NCT05303064 is a Phase 3 study evaluating weight gain in pediatric subjects with Schizophrenia or Bipolar I Disorder.
Yes, OLZ/SAM is being studied in pediatric patients aged 10 years and older. Clinical trials include a Phase 3 long-term safety extension study, a completed Phase 1 study, and a Phase 3 study evaluating weight gain, all focusing on pediatric subjects with Bipolar I Disorder or Schizophrenia.