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

Sponsor
Supernus Pharmaceuticals, Inc.
Study ID
NCT03924492
Status
Approved For Marketing

Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Status verified
Jun 2019

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