FDA Approves First Medication for Treatment of Postpartum Depression
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Describe the dosing and administration of brexanolone 2. Discuss the adverse events associated with brexanolone and the REMS program
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from through , participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
The FDA approved the first drug, brexanolone, specifically for postpartum depression (March 2019) under Priority Review and Breakthrough Therapy designation (see ‘Learn More – Primary Sources’ below for definition of these programs). Brexanolone is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator.
Dosage and Administration
Brexanolone is given as an IV infusion over 60 hours (2.5 days)
0 to 4 hours: 30 mcg/kg/hour
4 to 24 hours: Increase to 60 mcg/kg/hour
24 to 52 hours: Increase dosage to 90 mcg/kg/hour
Can consider a dosage of 60 mcg/kg/hour for those who do not tolerate 90 mcg/kg/hour
52 to 56 hours: Decrease to 60 mcg/kg/hour
56 to 60 hours: Decrease to 30 mcg/kg/hour
Note: Due to risks of adverse events (see below), a healthcare provider must
Be available on site to continuously monitor the patient throughout the infusion
Intervene as necessary, for the duration of the infusion
Warnings and Precautions
Suicidal Thoughts and Behaviors | Worsening postpartum depression
Consider changing or discontinuing medication
Most common ≥5% and at least 2X rate of placebo
Sedation | Somnolence
Loss of consciousness
Flushing | Hot flush
Risk Evaluation and Mitigation Strategy (REMS)
Brexanolone is only available via a restricted distribution program at certified health care facilities due to monitoring requirements (see above)
Patients must be enrolled in REMS prior to drug administration
Patients must be monitored for excessive sedation and sudden loss of consciousness including using continuous pulse oximetry monitoring
During infusion, patients must be accompanied during interactions with their child(ren)
Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away
Evidence of Efficacy
Two clinical RCTs (see reference in ‘Learn More – Primary Sources’ below)
Study 1: Participants with severe postpartum depression randomized to (1:1:1) to brexanolone 90 μg/kg per h (BRX90), brexanolone 60 μg/kg per h (BRX60), or matching placebo for 60 hours
Study 2: Participants with moderate postpartum depression randomized (1:1) to BRX90 or matching placebo for 60 hours
Primary outcome: Mean change from baseline in depressive symptoms (using 17-item Hamilton Rating Scale for Depression)
Brexanolone was shown to be superior to placebo at the end of the infusion and at 30 days
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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