A Postpartum Depression Drug Is Hitting The Market, But A \u200cBetter Alternative Already Exists<\/strong><\/p>\n<\/p>\n

The first\u2064 FDA-approved\u200d drug in pill form to treat\u2064 postpartum depression<\/a>, Zurzuvae, is expected to hit the market\u2063 next month,\u200b with pricing starting at nearly $16,000 for a two-week course of treatment. \u2064Meanwhile, progesterone replacement\u2064 therapy, a \u200dsafe, \u2064cheap, and \u2064effective\u200c treatment, available on the market for as low\u200d as 36\u200b cents \u200cper capsule<\/a>, continues to be \u2062ignored by most \u200bU.S. doctors.<\/p>\n

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Pharmaceuticals can\u2019t solve what traditional American health care is plagued by \u2014 a lack of \u200bindividualized, high-quality\u200c care for women, especially around fertility,\u200c pregnancy, and postpartum.<\/p>\n
\u201cWomen\u2019s health care in America is an insult to women,\u201d said Dr. Timothy \u200dMillea, orthopedic surgeon and Health Care Policy \u200cCommittee chair for the Catholic Medical Association, in\u2062 an interview.<\/p>\n
No\u2064 other developed nation comes\u200d close to America\u2019s rising \u2063maternal death rate<\/a>; next in \u2064line, \u2064France, has three times fewer deaths<\/a> per live birth each year.<\/p>\n
Data gathered in\u200d 2021 and published\u2064 in the \u200cAmerican Journal of Obstetrics and Gynecology<\/a> found nearly 20 percent of women suffer from postpartum depression, or\u2062 PPD. The current line of treatment is psychotherapy and slow-acting selective serotonin reuptake inhibitors (SSRIs), \u2062which are low-risk but can take several weeks to be effective.<\/p>\n
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\u201cWomen\u200b really\u200d need a lot of care postpartum,\u201d said Dr. Teresa Hilgers, \u2062 OB-GYN at the Saint Paul VI Institute<\/a> in Omaha, Nebraska. \u201cWe need to be monitoring for PPD<\/strong>. \u2063It can occur in anyone who \u2063has no\u200c risk factors. The \u200crisk goes up naturally for all women.\u201d<\/p>\n
Costly New Drug<\/h2>\nOn Nov. \u200b7, Sage Therapeutics, in partnership with \u200bBiogen, announced\u2063 long-anticipated pricing and market availability<\/a> for their new drug. Zurzuvae, found to reduce depression symptoms within days\u200b for most women, with continued psychiatric benefits for four to six weeks, was approved by the FDA in August<\/a> and \u200dclassified as a Schedule \u2064IV<\/a> drug by the\u2064 Drug Enforcement Agency.<\/p>\n
Sage\u2019s first\u200c attempt \u200dat the postpartum market, Zulresso<\/a>, 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.<\/p>\n
Long-Term Concerns<\/h2>\n
A drug\u2019s real value can only be determined\u200d compared to the current \u200cstandard of care, said Gregg\u200b Girvan, a Foundation for Research on\u2063 Equal Opportunity\u2064 scholar. Subjects in the\u2062 Zurzuvae\u2062 trial were given either a drug or placebo and stratified based on whether the participant was also \u2063taking an antidepressant at the \u2064time of the study.<\/p>\n
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\u201cPayers need to aggressively negotiate with Sage based on the\u2063 fact\u200d that, after a certain time period, the results between Zurzuvae\u200c and\u2064 SSRIs appear to converge,\u201d Girvan said.<\/p>\n
Furthermore, Sage\u2019s studies \u2062on Zurzuvae\u200b are \u2062short-term.\u2062 There is limited long-term\u2063 data on the drug. Hormone\u200b fluctuations, particularly \u200cpresent in \u200cbreastfeeding \u2062mothers\u2063 and those with thyroid \u2064disease, can exacerbate \u200bmental health conditions \u200bfor several months postpartum, \u2062far beyond the Zurzuvae trials.<\/p>\n
\u201cIf you \u200clook at it from \u2064the 30,000-foot view, that\u2019s \u2062problematic,\u201d Millea said. \u201cIt\u2019s \u200creally, really good that \u200dyou have women feeling better after a \u2062few days, but\u2063 what about\u200d a few weeks? What \u200chappens after six weeks?\u201d<\/p>\n
Bioidentical\u200d Hormone Treatment<\/h2>\n
The superiority of bioidentical hormone therapy\u2063 over synthetics is evident<\/a>. The side effects \u200bof synthetics include breast cancer, strokes, \u2064and heart disease, with many lesser, uncomfortable symptoms \u200dreported.<\/p>\n
Zuranolone is a synthetic of allopregnanolone, a \u200cneurosteroid \u2063the body derives \u200bfrom progesterone. Pharmaceutical companies cannot patent bioidentical\u2063 hormones, just\u2063 synthetic versions. Women are \u200dleft to suffer the difference in\u2064 cost and treatment.<\/p>\n
Doctors at the Paul VI Institute have a postpartum protocol using bioidentical progesterone to treat depression, anxiety,\u2063 and hormone imbalances<\/a>, that is inexpensive, safe, and readily\u200c available on\u200c the market, but not \u200dwidely used.<\/p>\n
\u201cWith the use of \u200dprogesterone postpartum, typically women feel better within hours, even 24 \u2064hours,\u201d Hilgers said. \u201cOnly 3.3 percent of\u2064 women did not have\u200d improvement in\u2062 their symptoms. The vast\u200b majority \u200bhave \u200cmoderate to marked improvement, mostly marked. Some women only need one dose.\u201d<\/p>\n
But a strong cancel culture \u2062and lack \u2064of pharmaceutical backing\u200b in women\u2019s care contribute to progesterone treatment not making it to the mainstream, Millea said.<\/p>\n
\u201cCancel culture for things outside the politically, medically \u2018correct\u2019 environment has been around a long time, especially in response to Catholic doctors,\u201d Millea said.<\/p>\n
With current women\u2019s health policy focused on abortion and synthetic hormones, health care providers<\/a> \u200bneed to buck the trend and speak up, offering \u2064the \u200dbest treatment options to women.<\/p>\n
\u201cTo the Biden administration\u2019s\u2063 FDA, an abortion \u200dis an expression of freedom, not the bondage\u2064 of mental health issues<\/a>\u200c and depression,\u201d Millea said. \u201cEighty percent or higher of \u2062women report mental health problems after abortion. To me this [drug] \u200dis \u200ba small project,\u200c a \u200bsmall success, but also\u2064 a glaring \u2063deficiency in recognizing \u200cpost-pregnancy mental health\u200c issues.\u201d<\/p>\n
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rnrn <\/p>\n
What are\u2063 the potential long-term concerns<\/a> and limitations of\u200c the Zurzuvae drug, and how does it compare to the benefits of progesterone replacement \u2064therapy in the long\u2062 run<\/h2>\n
A Postpartum \u2063Depression Drug\u2062 Is Hitting \u200cThe \u200bMarket, But A Better Alternative Already\u200d Exists<\/p>\n
The first FDA-approved drug in\u200b pill form to treat\u2063 postpartum depression,\u200d Zurzuvae, is expected to hit the market next month, with \u2064pricing starting at nearly $16,000 for a two-week course \u200bof \u200btreatment. Meanwhile, progesterone replacement \u2063therapy, a safe, cheap,\u200b and effective treatment,\u200d available on the market for as low as 36 cents per capsule, continues to be ignored by most U.S. doctors.<\/p>\n
Pharmaceuticals \u2063can’t solve what traditional American \u200bhealth care is plagued \u2062by\u200d \u2014 a\u2064 lack of individualized, high-quality care<\/a> for women, especially \u2062around fertility,\u200d pregnancy, and postpartum.<\/p>\n
“Women’s health care\u200d in America is an\u200d insult to women,” said Dr. \u2064Timothy Millea, orthopedic surgeon and Health Care Policy Committee \u2063chair\u2063 for the Catholic Medical Association, in an interview.<\/p>\n
No other developed nation\u2062 comes close to America’s\u200b rising maternal death rate; next in line, France, has three times fewer\u200d deaths per live birth each \u2062year.<\/p>\n
Data gathered in 2021 and published in the American Journal of Obstetrics and \u2063Gynecology found nearly \u200b20 percent\u2062 of women suffer from postpartum depression, or\u2063 PPD.\u200b The current line of treatment is psychotherapy and slow-acting selective serotonin reuptake inhibitors (SSRIs), which are\u2062 low-risk but can take several weeks to be effective.<\/p>\n
“Women really need a lot of care postpartum,” said Dr. \u200dTeresa Hilgers, OB-GYN at the Saint Paul VI\u2063 Institute in Omaha, Nebraska. “We need\u2064 to be monitoring for PPD.\u200b It can occur in anyone who has no risk factors. The risk \u2062goes\u200d up\u2064 naturally for \u2063all women.”<\/p>\n
Costly New Drug<\/p>\n
On Nov. 7, \u200dSage Therapeutics, in partnership with Biogen, announced long-anticipated pricing \u200dand \u200cmarket\u2062 availability for their new drug. \u200bZurzuvae, found to\u2063 reduce depression symptoms within days for most women,\u2063 with continued psychiatric benefits for four to\u200d six weeks,\u200c was approved by the FDA in August and classified as a Schedule IV drug by the Drug Enforcement Agency.<\/p>\n
Sage’s first\u2062 attempt at the postpartum\u2064 market, \u2062Zulresso, was considered successful, but the drug was too \u200bcostly and cumbersome \u200dfor widespread \u2063use, requiring a multi-day intravenous administration and costing about $34,000.<\/p>\n
Long-Term Concerns<\/p>\n
A drug’s real value can only be determined compared to the current standard of care,\u2063 said Gregg Girvan, a Foundation for Research on Equal \u200dOpportunity scholar. Subjects in the Zurzuvae trial were given \u200deither a drug or placebo and stratified based on whether the participant \u2062was also taking an antidepressant at the \u200ctime of the study.<\/p>\n
“Payers need \u200cto aggressively negotiate with Sage based on the fact that, after a certain time period, the results between Zurzuvae and SSRIs appear to converge,” Girvan \u200csaid.<\/p>\n
Furthermore, Sage’s studies on Zurzuvae are\u200b short-term. There\u2064 is limited long-term data\u2064 on the \u200cdrug. Hormone fluctuations, particularly present in breastfeeding mothers\u2064 and \u200bthose with thyroid disease, can exacerbate mental \u200dhealth conditions for several months postpartum, \u200dfar beyond the Zurzuvae trials.<\/p>\n
“If you look at it from \u2063the 30,000-foot\u2064 view, that’s problematic,” Millea said. “It’s really, \u2062really good that you have women feeling better after a few \u200bdays, but what about a few weeks? What happens \u200bafter\u200d six weeks?”<\/p>\n
Bioidentical Hormone Treatment<\/p>\n
The superiority of bioidentical\u2064 hormone therapy over \u200dsynthetics is evident. The side effects of \u200csynthetics \u2063include \u2063breast cancer, strokes, and heart disease, \u2063with\u200b many lesser, uncomfortable symptoms reported.<\/p>\n
Zuranolone is \u2063a \u200dsynthetic of allopregnanolone, a neurosteroid the body\u200b derives \u200bfrom \u2063progesterone. Pharmaceutical\u200d companies are often driven by profits, leading them to develop and market new drugs rather than promoting \u200bexisting, safer alternatives.<\/p>\n
In conclusion, while the FDA-approved postpartum depression drug Zurzuvae is making \u2063its way to the market, it is crucial to acknowledge the availability\u200d of a \u2063better alternative – progesterone replacement\u200c therapy. Traditional American health care needs to prioritize individualized, \u200dhigh-quality care for women’s health, especially during the crucial phases of fertility, pregnancy, and postpartum. It’s time for doctors\u200d and\u200b medical professionals \u2064to\u2062 explore \u200band embrace safer and \u200cmore affordable \u2062options like progesterone replacement therapy for the well-being\u200c of \u2063women.<\/p>\n","protected":false},"excerpt":{"rendered":"
Alternative, has been used for years to treat postpartum depression. It is concerning that Zurzuvae is being marketed at such a high price when a better and more affordable option already exists. Progesterone replacement therapy should be considered as a viable alternative for treating postpartum depression<\/p>\n","protected":false},"author":638,"featured_media":2108479,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[546],"tags":[],"class_list":["post-2108478","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-federalist"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2108478","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/638"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2108478"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2108478\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2108479"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2108478"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2108478"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2108478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}