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from Pharmacy Times – January 14, 2020
by Jill Murphy

Each year, around 20% of new mothers will experience postpartum depression (PPD) after giving birth, which can affect a woman’s daily life, such as their relationships with others and caring for their children.1

In March 2019, the FDA approved the brexanolone (Zulresso, Sage Therapeutics) injection for intravenous (IV) use for the treatment of PPD in adult women. This was the first drug approved by the FDA specifically for this disorder.2

Health care providers can review brexanolone with mothers before these patients invest in the procedure. Grace Fox, a pharmacy researcher at Lumere with a background in psychiatry, elaborated on the administration process of brexanolone and other factors that many mothers may not know before they go into the process, in an interview with Pharmacy Times.

Brexanolone has become a game changer for some mothers that have experienced severe symptoms of PPD. However, this option is not a first line therapy for every patient.

“For patients with mild to moderate PPD where psychotherapy has been shown to be effective, and is guideline recommended, brexanolone is not going to be a first line therapy for them,” Fox said.

Cost is a factor that some patients may want to consider. Brexanolone’s price, on average, is $34,000 per patient for a course of treatment, prior to discounts and reimbursements being applied.3

“Not only is the cost a great price to pay, but there are other costs that need to get taken into account,” Fox said. “Other costs include administration in a setting with risk mitigation strategy as well as ongoing adverse event monitoring.”

Brexanolone takes 60 hours—or 2.5 days—to administer. However, it has a rapid effect, with patients reporting effects within 24 hours after the completion of the procedure.

“For patients who have severe PPD, the rapid onset is critical, especially in the case where suicide is a realistic outcome,” Fox said. “Many women treated with off-label therapies do not achieve adequate response or full-remission of depressive symptoms.”

In addition to learning about brexanolone from health care providers, patients and their families have access to a support program operated by Sage. Program services include access to case managers that can provide information throughout the treatment process, support with insurance understanding and coverage options, financial assistance to eligible patients, and access to educational resources in their communities.4

There are other treatment options that can be considered when it comes to PPD, according to Fox. “Antidepressants are oral tablets at a lower cost, and a slower pace of about 4-6 weeks until it takes effect,” she said.

Additional medications may be on the horizon. For example, SAGE-217 and ganaxolone are 2 oral options in the drug pipeline that could offer less of a process to administer, and at a lower cost than brexanolone.

REFERENCES

  1. Facts about postpartum depression. Illinois Department of Public Health. http://www.idph.state.il.us/about/womenshealth/factsheets/pdpress.htm. Accessed November 25, 2019.
  2. Coppock, Kristen. FDA approves first drug for postpartum depression. Pharmacy Times. https://www.pharmacytimes.com/resource-centers/womens-health/fda-approves-first-drug-for-postpartum-depression. Published March 20, 2019. Accessed January 13, 2020.
  3. McGinley L, Bernstein L. First drug specifically for postpartum depression is approved. Washington Posthttps://www.washingtonpost.com/health/2019/03/19/first-drug-specifically-postpartum-depression-is-approved/ Published March 19, 2019. Accessed January 13, 2020.
  4. Sage Therapeutics. Patient Support. 2019. https://www.sagerx.com/patients-caregivers/patient-support/. Accessed January 14, 2020.


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