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SAGE-547 60 μg/kg/h · 1 trial · 1 indication
The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group. |
| SAGE-547 60 μg/kg/h | EXPERIMENTAL | Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours). |
| SAGE-547 90 μg/kg/h | EXPERIMENTAL | Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h. |
| SAGE-547 60 μg/kg/h | DRUG | Intravenous infusion of SAGE-547. |
| SAGE-547 90 μg/kg/h | DRUG | Intravenous infusion of SAGE-547. |
Key Inclusion Criteria: * Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infu...
SAGE-547 60 μg/kg/h is an investigational small molecule being studied for the treatment of postpartum depression. It is a synthetic neurosteroid that has been evaluated in a Phase 3 clinical trial for this condition. The drug is administered intravenously at a dose of 60 μg/kg/h.
SAGE-547 60 μg/kg/h is a small molecule that acts as a positive allosteric modulator of GABA-A receptors. By enhancing the inhibitory effects of GABA, it aims to rapidly reduce the symptoms of postpartum depression. This mechanism is thought to help restore the balance of excitatory and inhibitory signaling in the brain.
SAGE-547 60 μg/kg/h is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company. The company is listed on the NASDAQ under the ticker symbol SUPN. Supernus is conducting clinical trials to evaluate the safety and efficacy of this drug for postpartum depression.
SAGE-547 60 μg/kg/h is in Phase 3 clinical development. It has completed a Phase 3 trial for postpartum depression, but it is not yet approved by the FDA. The drug remains investigational and is still undergoing clinical evaluation to determine its safety and effectiveness.
SAGE-547 60 μg/kg/h has been studied in a Phase 3 clinical trial with the identifier NCT02942004. This trial, titled 'A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression,' was completed in the United States. It enrolled 138 female participants aged 18 years and older.
SAGE-547 60 μg/kg/h is a formulation of brexanolone, a synthetic neurosteroid. Brexanolone is the generic name for this compound, which has been studied for postpartum depression. The drug is also known by the brand name Zulresso in some contexts, though this specific dosage form is being developed by Supernus Pharmaceuticals.