Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression

NCT03924492 | Unknown

• 1 other identifier: 547-PPD-401
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.

Conditions

Postpartum Depression

Keywords

Expanded Access

Interventions

ZULRESSO (brexanolone) injection DRUG

ZULRESSO

Also known as: Brexanolone, SAGE-547

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed an informed consent form prior to any study-specific procedures being performed
• Subject is an ambulatory female at least 18 years of age
• Subject agrees to adhere to the study requirements
• Subject agrees not to be the primary caregiver of any dependents during the infusion
• Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
• Subject has a current diagnosis of PPD, as assessed by the Investigator

You may not qualify if:

• Subject has end stage renal disease
• Subject has a known allergy to progesterone or allopregnanolone

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Depression, Postpartum

Interventions

brexanolone; Injections

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Last Updated: September 15, 2025

Record last verified: 2019-06