Sage Therapeutics’ Zulresso (brexanolone) Receives FDA’s Approval for Postpartum Depression (PPD)

 Sage Therapeutics’ Zulresso (brexanolone) Receives FDA’s Approval for Postpartum Depression (PPD)

Sage Therapeutics’ Zulresso (brexanolone) Receives FDA’s Approval for Postpartum Depression (PPD)

Shots:

  • 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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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