A pill for PPD has been fast-tracked for FDA authorization

Postpartum depression (PPD) is incredibly common: The most recent statistics show that 1 in 7 women will experience PPD in the 12 months after giving birth.

Currently, there’s just one FDA-approved drug on the market that treats postpartum depression—but it’s not widely available. That drug, brexanolone (Zulresso), is administered over the course of 60 hours through an IV drip. It’s also expensive: without insurance, it costs $34,000.

There’s good news, though: Drug makers Biogen and Sage Therapeutics recently applied for FDA authorization for zuranolone, a fast-acting antidepressant in pill form that has been shown to be effective in treating PPD. Taken once a day for 14 days, it could be a game-changer for those struggling with PPD. The FDA is now fast-tracking the application for zuranolone in the treatment of PPD and major depressive disorder (MDD), granting it priority review status. A decision date is currently set for Aug. 5, 2023.

Studies on Zuranolone for PPD

A randomized, double-blind, placebo-controlled Phase 3 trial of zuranolone looked at 151 women with severe PPD, and demonstrated that the drug led to a “significant reduction” in symptoms. By day 3, women receiving zuranolone experienced a greater reduction in depression scores than women receiving placebo, and PPD symptom reduction continued to decrease up to day 15.

More than half of the women who took the pill were in full remission by the end of the 45 day trial period.

JAMA Psychiatry

Side effects of taking zuranolone seem to be mild to moderate, with the most common side effects including fatigue, dizziness, headache, nausea and diarrhea. In contrast, side effects of Zulresso can be more severe, including excessive sedation and sudden loss of consciousness in some cases. Zulresso may also take longer to have an effect on symptoms.

“Existing treatments often take weeks to months to provide symptom relief, and patients may need to cycle through multiple treatment options to fully address their symptoms. People with MDD and PPD deserve better,” said Laura Gault, MD, PhD, Chief Medical Officer at Sage, to Business Wire. “We believe that zuranolone, if approved, could evolve the way depression is treated and this submission brings us one step closer to that goal.”

A PPD pill on the horizon

The potential for a PPD pill is huge. A well-tolerated, fast-acting PPD treatment that can help patients get back to their life sooner could mean better bonding for new mother-baby dyads in the early weeks and months after birth, which can have long-term benefits for development and attachment.

The continued push for accessible treatments for PPD underscores the fact that this highly common condition isn’t something people just have to live with. “Depression is not an identity, it’s an episodic disorder that we hope in the future to be able to treat quickly with treatments that are well-tolerated and with benefits that last,” says Anita H. Clayton, MD, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, in a press release.

In the meantime, if you or someone you know may be struggling with PPD, there are resources and practitioners who can help. The first step to getting the treatment you need is getting in front of a medical health professional.

“Postpartum depression negatively impacts women, their families, and it is often under-diagnosed and under-treated,” says Dr. Kristina Deligiannidis, the trial’s principal investigator and lead author on the paper, in a press release. “These encouraging results are an important step in efforts to develop a novel treatment option for patients who suffer from this prevalent condition.”

Here are potential symptoms and signs of postpartum depression to look out for:

• Feeling sad for long periods of time without an easy-to-pinpoint cause
• Lack of desire to do the things you used to love
• Difficulty getting out of bed
• Difficulty falling asleep
• Lack of motivation
• Feeling guilty often
• Anger or rage
• Worrying about things that seem odd or that you weren’t previously worried about
• Repetitive thoughts or actions, such as the need to clean something over and over or ensure that a door is locked multiple times
• Fear of being left alone with your baby
• Reliving difficult aspects of your birth
• Not wanting to talk or think about your birth at all
• Inability to make decisions
• Intrusive and disturbing thoughts
• Unable to sit still
• Not feeling bonded to your baby

Sources

Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R.  Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial.  JAMA Psychiatry. 2021 Jun 30. 

A portion of this post was excerpted from “The Motherly Guide to Becoming Mama” A version of this post was originally published on July 21, 2021. It has been updated.