A few weeks ago, we posted an article about postpartum depression (PPD). This condition afflicts 11% to 18% of new mothers, and for 38% of those women, the condition becomes chronic.
We noted that victims of PPD feel profoundly sad, hopeless, empty, and useless. “Postpartum depression is a serious condition that, when severe, can be life-threatening,” says Dr. Tiffany Farchione, director of the Division of Psychiatric Products at the FDA.
When it comes to the treatment of PPD, we wrote, the standard approaches emphasize counseling, particularly cognitive behavioral therapy.
Our observation that “Antidepressant medications are also available to help regulate mood” was little more than a footnote.
Given the antidepressant medications that are now available, our dismissive attitude toward PPD medication was appropriate. Anti-PPD drugs in the current armory of physicians who are treating PPD take anywhere from 2 to 4 weeks to take effect. And the relief those drugs provide usually lands somewhere in the minimal to moderate range.
FDA approves the first drug for postpartum depression
Well, stop the presses. The FDA has approved a brand-new fast acting anti-postpartum depression medication, named Zulresso. The approval was accelerated because the FDA categorized Zulresso as a “breakthrough” drug, entitled to fast track processing.
What is Zulresso and how does it work?
Zulresso is a synthetic form of allopregnanolone, a hormone produced by progesterone in the brain.
Zulresso may help ease the symptoms of PPD by reducing the neural activity associated with depression, according to Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina. (Dr. Meltzer-Brody was the principal investigator for the Zulresso research project.)
247 women participated in the clinical trials which led to the FDA approval. They reported significant relief from their PPD symptoms within 10 to 14 hours after the drug first entered their bloodstreams. That level of relief persisted for at least 30 days (there has not yet been any systematic research on longer-term results.)
About 75% of the participants in the Zulresso clinical trials were at least 50% improved in their PPD symptoms immediately after the administration protocol was completed. 94% had not relapsed as of the 30-day follow-up.
Zulresso for postpartum depression will be publicly available this coming June
In this case, however, “publicly available” definitely does not equate to “readily accessible”.
Zulresso is administered during a continuous 60-hour infusion regimen. During the tests which led to the FDA’s approval, many women became dizzy and some lost consciousness. This means that the 2½ day infusion process must take place within a medically supervised setting.
What is the price of this new PPD treatment?
According to Sage Therapeutics, the Connecticut-based manufacturer of the new drug, the dosage required for treatment will cost about $34,000.
That $34,000 is for the drug itself. The costs for the three-day inpatient stay and the costs of the attending medical staff are all additional. But insurance coverage is still being evaluated.
PPD is more prevalent among women who are struggling financially. Given the costs of this new medication, both in money and time, the women most in need of this relief will be the least likely to receive any of the promised benefits of this new “breakthrough”.
One very positive side effect from Zulresso has been reported, however. All this good news has caused the market price of Sage stock to surge by 64% this year.
We’re glad, of course, that some women will soon be able to achieve prompt relief from the very serious effects of postpartum depression. But we’re also hopeful that pending legislation will reign in the costs of such medication. The benefits of this breakthrough should be more readily available to all women who desperately need relief from PPD.
About Dr. Thaïs Aliabadi
As one of the nation’s leading OB-GYNs, Dr. Thaïs Aliabadi offers the very best in gynecological and obstetric care. Together with her warm professional team, Dr. Aliabadi supports women through all phases of life. She fosters a special one-on-one relationship between patient and doctor. We invite you to establish care with Dr. Aliabadi. Please click here to make an appointment or call us at (844) 863-6700.