Trials / Approved For Marketing
Approved For MarketingNCT03924492
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZULRESSO (brexanolone) injection | ZULRESSO |
Timeline
- First posted
- 2019-04-23
- Last updated
- 2025-09-15
Source: ClinicalTrials.gov record NCT03924492. Inclusion in this directory is not an endorsement.