A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting

The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Drug: ZULRESSO®

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Culver City, California, United States, 90230
      • Sage Investigational Site
    • Culver City, California, United States, 90230
      • Virtual Site (recruiting nationwide)
  • Florida
    • Miramar, Florida, United States, 33029
      • Sage Investigational Site
    • Pompano Beach, Florida, United States, 33060
      • Sage Investigational Site
  • New York
    • New York, New York, United States, 10036
      • Sage Investigational Site
  • Texas
    • League City, Texas, United States, 77573
      • Sage Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ambulatory female ≥18 years of age.
2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
3. Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
4. Participant has no history of sleep apnea or any clinically significant respiratory conditions.
5. Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.

7. Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:

   • safe environment for the home infusion provider staff.
   • access to a working telephone.
   • electricity and grounded electrical outlets.
   • running water.
   • access to back-up emergency services (911 service or ambulance availability).
   • sanitary environment.
8. Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.

Exclusion Criteria:

1. Participant has end stage renal failure.
2. Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
3. Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZULRESSO®; Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.	Drug: ZULRESSO®; Intravenous infusion of ZULRESSO®.; Other Names: SAGE-547; Allopregnanolone; Brexanolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal.	Up to Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®	Nonadherence was defined by failure of any of following: Home infusion provider to train all pharmacy and home healthcare providers (HHPs) in dispensing/administration of ZULRESSO® on risk of excessive sedation/loss of consciousness; HHPs to counsel participants on risk of excessive sedation/loss of consciousness; Deliver ZULRESSO® per protocol; Provide preprogrammed peristaltic pump; HHP:assess excessive sedation every 2 hours in planned nonsleep periods, change infusion bag per protocol, at least one HHP available in participant's home for the duration of infusion; Fall protocol in place; Monitor participants with pulse oximeter; Stop infusion when participant is primary caregiver of dependents and/or identification of excessive sedation/loss of consciousness/hypoxic episode; Caution participants post-infusion against engaging in hazardous activities requiring mental alertness; Complete AE of special interest/Serious AE form; Infusion resumed after hypoxia episode	Up to Day 3
Number of Use-Related Issues Related to the Home Administration of ZULRESSO®	Home healthcare provider (HHP) staff completed checklists at end of each day and/or shift to document any use-related issues throughout duration of infusion. Any use-related issues determined to be critical in nature were followed up immediately and were reported adequately. Use-related issues were categorized as Critical Use Error (UE): HHP failed to complete a task or made uncorrected use error during task that could have resulted in harm, compromised medical care, incidence of nonadherence with safe use conditions for administration of ZULRESSO, or incidence of use-related issues related to home administration of ZULRESSO; Use Difficulty (UD): HHP successfully completed a task but did so while experiencing issues/operational difficulties; Close Call (CC): HHP committed error that could have led to a task failure, but self-corrected and completed task successfully. Multiple occurrences of issue throughout a single infusion was included only once in total.	Up to Day 3
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to nearest single decimal.	Up to Day 3
Percentage of Participants With Medication Error	Medication error was any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication was in the control of the healthcare professional, participant, or consumer. Percentages are rounded off to the nearest single decimal.	At screening and during the study (Up to Day 3)

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): July 14, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnanolone; brexanolone
• Other Study ID Numbers: 547-PPD-404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No