The U.S. Food and Drug Administration (FDA) on August 4 approved the first oral medication, Zurzuvae (zuranolone), for the treatment of post-partum depression (PPD).
Developed by Biogen and Sage Therapeutics, the new treatment can be taken at home, over a relatively short two-week period, and it often starts reducing depression in a matter of days, clinical trials showed.
The highly anticipated announcement of Zurzuvae’s approval brings a great deal of hope for patients and families grappling with the often-overwhelming effects of peri- and post-natal depression.
The importance of post-partum depression treatment
According to the Centers for Disease Control and Prevention (CDC), 1 in 8 women report being depressed after birth—whether “baby blues” or post-partum depression. Yet, this depression remains untreated in approximately 50% of the cases. An estimated 500,000 women experience symptoms of PPD in the U.S.
FDA describes PPD as “a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because post-partum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”
Increasing awareness of PPD has led to an alteration of the stigma associated with mental health over the last decade, according to reports. Early recognition of symptoms and reporting allows patients and families access to treatment, which up until a few years ago, included antidepressants and therapy.
The history of post-partum depression treatment
The first medical treatment specifically targeted at PPD became a reality in 2019. An IV infusion that takes over 2.5 days with some adverse effects, Zulresso (brexanolone) was only approved for patients at certified centers under close supervision, according to the FDA.
Brexanolone is a neuroactive steroid (NAS) gamma-aminobutyric acid (GABA)-A receptor-positive allosteric modulator (PAM). GABA is an inhibitory signaling pathway in the brain and is involved in neurologic and central nervous system function. Low levels of GABA in the brain have been associated with anxiety and depression, according to studies.
Aside from being an expensive option, risks of brexanolone include excessive sedation and sudden loss of consciousness requiring continuous pulse oximetry, FDA said.
What Zurzuvae achieves
The quest for a compatible alternative for patients was reached following two randomized, double-blinded, multicenter studies. Patients taking Zurzuvae saw their scores on a standard depression scale improve by 50% or more. Taken once daily over the course of two weeks, Zurzuvae promises rapid improvement in depressive symptoms in as early as three days without the requirement of in-hospital administration.
As with Zulresso, Zurzuvae acts as a NAS GABA-A receptor PAM and does not work directly on the neurotransmitters (serotonin, dopamine, norepinephrine) associated with standard anti-depressants. They do, however, contain a synthetic version of a neuroactive steroid called allopregnanolone, which is a hormone produced from progesterone and targets mood neurotransmitters.
Recommendations for women who are breastfeeding or with a long-standing history of depression or suicidal ideation remain under investigation, The New York Times said. Patients with mild to moderate depression accompanied by anxiety and somnolence, as well as those with incomplete response to anti-depressants, may obtain the biggest benefit.
Though it is marketed as an oral tablet and does not necessitate pulse oximetry and hourly professional monitoring, Zurzuvae side effects include somnolence, dizziness, and fatigue, according to Biogen. Patients are also discouraged from driving and may require some at-home observation to assure tolerance. Despite these factors, the ease of an oral formulation supports post-partum bonding between the mother and infant during a time that is notably crucial for early child development.
Post-partum depression is a global issue and affects millions of families each year. The availability of an affordable, fast-acting treatment option for women brings new light into a discussion that began decades ago. Treatment for patients that do not qualify for Zurzuvae is supportive and research is ongoing.