A Postpartum Depression Drug Is Hitting The Market, But A Better Alternative Already Exists
The first FDA-approved drug in pill form to treat postpartum depression, Zurzuvae, is expected to hit the market next month, with pricing starting at nearly $16,000 for a two-week course of treatment. Meanwhile, progesterone replacement therapy, a safe, cheap, and effective treatment, available on the market for as low as 36 cents per capsule, continues to be ignored by most U.S. doctors.
Pharmaceuticals can’t solve what traditional American health care is plagued by — a lack of individualized, high-quality care for women, especially around fertility, pregnancy, and postpartum.
“Women’s health care in America is an insult to women,” said Dr. Timothy Millea, orthopedic surgeon and Health Care Policy Committee chair for the Catholic Medical Association, in an interview.
No other developed nation comes close to America’s rising maternal death rate; next in line, France, has three times fewer deaths per live birth each year.
Data gathered in 2021 and published in the American Journal of Obstetrics and Gynecology found nearly 20 percent of women suffer from postpartum depression, or PPD. The current line of treatment is psychotherapy and slow-acting selective serotonin reuptake inhibitors (SSRIs), which are low-risk but can take several weeks to be effective.
“Women really need a lot of care postpartum,” said Dr. Teresa Hilgers, OB-GYN at the Saint Paul VI Institute in Omaha, Nebraska. “We need to be monitoring for [PPD]. It can occur in anyone who has no risk factors. The risk goes up naturally for all women.”
Costly New Drug
On Nov. 7, Sage Therapeutics, in partnership with Biogen, announced long-anticipated pricing and market availability for their new drug. Zurzuvae, found to reduce depression symptoms within days for most women, with continued psychiatric benefits for four to six weeks, was approved by the FDA in August and classified as a Schedule IV drug by the Drug Enforcement Agency.
Sage’s first attempt at the postpartum market, Zulresso, was considered successful, but the drug was too costly and cumbersome for widespread use, requiring a multi-day intravenous administration and costing about $34,000.
A drug’s real value can only be determined compared to the current standard of care, said Gregg Girvan, a Foundation for Research on Equal Opportunity scholar. Subjects in the Zurzuvae trial were given either a drug or placebo and stratified based on whether the participant was also taking an antidepressant at the time of the study.
“Payers need to aggressively negotiate with Sage based on the fact that, after a certain time period, the results between Zurzuvae and SSRIs appear to converge,” Girvan said.
Furthermore, Sage’s studies on Zurzuvae are short-term. There is limited long-term data on the drug. Hormone fluctuations, particularly present in breastfeeding mothers and those with thyroid disease, can exacerbate mental health conditions for several months postpartum, far beyond the Zurzuvae trials.
“If you look at it from the 30,000-foot view, that’s problematic,” Millea said. “It’s really, really good that you have women feeling better after a few days, but what about a few weeks? What happens after six weeks?”
Bioidentical Hormone Treatment
The superiority of bioidentical hormone therapy over synthetics is evident. The side effects of synthetics include breast cancer, strokes, and heart disease, with many lesser, uncomfortable symptoms reported.
Zuranolone is a synthetic of allopregnanolone, a neurosteroid the body derives from progesterone. Pharmaceutical companies cannot patent bioidentical hormones, just synthetic versions. Women are left to suffer the difference in cost and treatment.
Doctors at the Paul VI Institute have a postpartum protocol using bioidentical progesterone to treat depression, anxiety, and hormone imbalances, that is inexpensive, safe, and readily available on the market, but not widely used.
“With the use of progesterone postpartum, typically women feel better within hours, even 24 hours,” Hilgers said. “Only 3.3 percent of women did not have improvement in their symptoms. The vast majority have moderate to marked improvement, mostly marked. Some women only need one dose.”
But a strong cancel culture and lack of pharmaceutical backing in women’s care contribute to progesterone treatment not making it to the mainstream, Millea said.
“Cancel culture for things outside the politically, medically ‘correct’ environment has been around a long time, especially in response to Catholic doctors,” Millea said.
With current women’s health policy focused on abortion and synthetic hormones, health care providers need to buck the trend and speak up, offering the best treatment options to women.
“To the Biden administration’s FDA, an abortion is an expression of freedom, not the bondage of mental health issues and depression,” Millea said. “Eighty percent or higher of women report mental health problems after abortion. To me this [drug] is a small project, a small success, but also a glaring deficiency in recognizing post-pregnancy mental health issues.”