- The approval is based on three clinical studies assessing Zulresso (brexanolone) vs PBO in women with moderate to severe PPD + ≤6 mos. postpartum at screening aged 18 to 45yrs.
- The three clinical study results: met 1EPs; reduction in Hamilton Rating Scale for Depression (HAM-D) score; reduction in depressive symptoms within a day; maintained effect through the 30-day follow-up
- Zulresso (brexanolone, IV) is an allosteric modulator of GABAA receptor and has received FDA’s PR, BT designation & EMA’s PRIME designation for PPD
Click here to read full press release/ article | Ref: Sage Therapeutics | Image: Third Rock Ventures