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In 2019, brexanolone, better known as Zulresso, became the first postpartum depression (PPD) drug to receive FDA approval. While we have previously discussed this IV medication for PPD in other episodes, there is now a novel oral version of this antidepressant which has made the news as of last week (ie, early august 2023). That medication was known as SAGE 217 during the clinical trials, but it is now known as zuranolone (ZURZUVAE™). YEP.. in the first week of August 2023, the US Food and Drug Administration approved the medication zuranolone for the treatment of postpartum depression – making it the first FDA-approved oral pill in the United States specifically for postpartum depression. Do you know how this medication works? What's the data on it? Does ACOG have an opinion on this? And what's the special FDA warning that ended up as a BLACK BOX on the approval? In this episode, we will learn the ins and outs of Zurzuvae.
Members of a search and rescue team from the Los Angeles County Fire Department are in Turkey assisting with earthquake recovery. LA firefighter Frank Infante speaks to us from Turkey. And, out-of-network ambulance bills can be extremely high and unaffordable for many patients. STAT's Bob Herman joins us. Then, the Food and Drug Administration is reviewing the first-ever pill to target postpartum depression. Psychiatrist Nancy Byatt and mother Stephanie Hathaway — who credits the drug Zulresso with saving her life — tell us more.
In this episode Sara and Ryan talk with Dr. Tom Smith about the current data regarding the use of antidepressants during pregnancy. They also briefly discuss the use of Zulresso in postpartum depression.Additional information can be found at: http://www.medicaidmentalhealth.org/ .
Zuranolone is a neurosteroid that is inching its way toward FDA approval in depression. In some ways it's similar to brexanolone (Zulresso) – the IV therapy approved in 2019 for postpartum depression – and in other ways it's different.CME: Take the CME Post-Test for this episodePublished On: 04/04/2022Duration: 12 minutes, 20 secondsRelated Articles: “Brexanolone: A New Treatment for Postpartum Depression,” The Carlat Psychiatry Podcast, August 2019“Brexanolone (Zulresso) for Postpartum Depression,” The Carlat Psychiatry Report, June 2019“Brexanolone: A New Treatment for Postpartum Depression,” The Carlat Psychiatry Report, January 2019Chris Aiken, MD, Kellie Newsome, PMHNP, and Margaret Chisolm, MD, have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.
https://astralcodexten.substack.com/p/highlights-from-the-comments-on-zulresso Thanks to everyone who commented on Zounds! It's Zulresso and Zuranolone and on the followup Progesterone Megadoses Might Be A Cheap Zulresso Substitute. I'm constantly impressed by the expertise of commenters here and on how much better the biomedical comment threads are compared to some of the others. Among the things I learned: — Metacelsus (who writes the blog De Novo) doubts the price estimates I posted: There's no way it costs $10,000 to $20,000 a gram at scale. Those 3 chemical supply companies specialize in having a very large catalog of small quantities of chemicals for biologists to test in their experiments. (I have personally ordered from 2 out of those 3 for my research.) The price they charge per gram is not competitive at all. He also wrote a longer blog post about the science of progesterone here. — Douglas (who writes the blog A Mindful Monkey) clears up some mechanism details I missed: From Stahl's: 'the precipitous decline in circulating and presumably brain levels of allopregnanolone hypothetically trigger the onset of a major depressive episode in vulnerable women. Rapidly restoring neurosteroid levels over a 60-hour period rapidly reverses the depression, and the 60 hour period seems to provide the time necessary for postpartum patients to accommodate their lower levels'. So the idea is the taper of the steroid is a helpful part.
https://astralcodexten.substack.com/p/progesterone-megadoses-might-be-a Earlier this week we talked about Zulresso, a new medication for post-partum depression. It works well, but it can only be administered at a few special hospitals, and costs $35,000 per treatment. But Zulresso is a natural metabolite of the female hormone progesterone. What's stopping people from taking progesterone, waiting for their bodies to metabolize it into Zulresso, and saving $35,000 and a hospital stay? As far as I can tell, nothing. Andreen et al give some people a dose of 20 mg progesterone, then measure allopregnanolone levels. They find that the progesterone gets converted into allopregnanolone, with a max plasma concentration of about 8 nmol/L. This is about a fifth of allopregnanolone levels during pregnancy, which a course of Zulresso is trying to match. So in theory (and assuming simple pharmacokinetics) a dose of 100 mg progesterone ought to give the same peak level of allopregnanolone as a Zulresso infusion. The only people I can find who take this to its logical conclusion are Barak & Glue. They do the same calculation as above much more rigorously, and suggest that the following progesterone regimen would correspond to the typical Zulresso infusion:
https://astralcodexten.substack.com/p/zounds-its-zulresso-and-zuranolone How excited should we be about the latest class of antidepressants? 1: What is Zulresso? Wikipedia describes Zulresso as “A bat-winged, armless toad with tentacles instead of a face... ” - no! sorry! That's Zvilpogghua, one of the Great Old Ones from the Lovecraft mythos. Zulresso is the brand name of allopregnanolone (aka brexanolone), a new medication for post-partum depression. It's interesting as a potential missing link between hormones and normal mood regulation. 2: What do you mean by “missing link between hormones and normal mood regulation?” Allopregnanolone is a naturally-occuring metabolite of the female hormone progesterone. In 1981, scientists found it was present in unusually high concentrations in the brain (including male brains), suggesting that maybe the brain was making it separately and using it for something. They did some tests and found that it was a positive allosteric modulator of GABA.
Heidi is a limited license clinical mental health counselor. A two-time survivor of perinatal mood disorders she has worked in the maternal mental health field for over eight years through peer support and training. Heidi has training through Postpartum Support International, The Bloom Foundation, and Postpartum Progress focusing on postpartum mood disorders, treatment, and therapy. Heidi's personal experience postpartum and as an Adult Child of an Alcoholic give her the knowledge and tools to help families through the transitions of parenthood and complex family systems. Heidi is passionate about supporting and guiding clients with other mood disorders as well including bipolar disorder and borderline personality disorder. Additionally, she is also a patient advocate for Sage Therapeutics, the leading developer of Zulresso the first and only FDA-approved medicine specifically for postpartum depression. Heidi is currently practicing counseling in the Metro Detroit area, for more information please contact Heidi directly at heidi@phoenixpathway.com .
This KGI Industry Talk features Ravneesh Sachdev, the Vice President and Head of Business Development at Sage Therapeutics, based in Cambridge, MA. Sage is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, including Zulresso™, the first FDA-approved drug specifically for postpartum depression. Ravneesh evaluates and transacts on partnerships in order to inorganically grow Sage’s business. Over the past 15+ years of his business development career, Ravneesh has contributed to, as well as led, the execution of more than 20 partnerships during his tenure at several other companies, namely Pfizer, Onyx Pharmaceuticals (now part of Amgen), UCB Pharma, Acorda Therapeutics, and Bioverativ (now part of Sanofi). Ravneesh earned his bachelor’s degree in Molecular Neuroscience from Claremont McKenna College, his Master of Business and Science degree from KGI, and his MBA in Healthcare Leadership from Yale University School of Management.
Did you hear there is a FDA approved IV infusion treatment for postpartum depression? 1 in 9 women suffer from postpartum depression (1). This could be a game changer for so many women. It’s called Zulresso! But what if you aren’t eligible and approved for Zulresso infusions? Recently, Motherly released an article that shared news about the SNOO from Happiest Baby possibly being covered by insurance if approved by the FDA! Word on the street is that SNOO may be approved by the FDA as a necessity for new parents. This could be a game changer for so many women. (1) Ko JY, Rockhill KM, Tong VT, Morrow B, Farr SL. Trends in postpartum depressive symptoms – 27 states, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66(6):153-158. (2) https://www.mother.ly/news/is-the-snoo-covered-by-health-insurance?rebelltitem=3#rebelltitem3 (3) https://www.happiestbaby.com/blogs/snoo/snoo-fda-approval Watch my FREE MASTERCLASS here: www.thebirthlounge.com/youridealbirth To join The Birth Lounge, click here: www.thebirthlounge.com
In this episode of Mommy Brain Revisited I talk with Dr Jamie Maguire an Associate Professor of Neuroscience in the Graduate School of Biomedical Sciences at Tufts University in the USA about her research on allopregnanolone, a neurosteroid, which formed the foundation for Zulresso (Sage Therapeutics) – the first unique treatment for Postpartum Depression. A great story from basic research in the maternal brain to clinical application. For more information on Dr. Maguire's research see: https://www.maguirelab.com/ For a direct link to her publications see: https://www.ncbi.nlm.nih.gov/pubmed/?term=maguire+jamie Questions, comments, suggestions - Get in touch www.jodipawluski.com / j.pawluski@gmail.com --- Support this podcast: https://anchor.fm/mommybrainrevisited/support
In March 2019, the FDA approved the first medication specifically targeted for postpartum depression, brexanolone (Zulresso). However, this medication requires a 60 hour, inpatient, IV-continuous infusion and there are some safety concerns. In May 2019, the Cleveland Clinic announced that it would release a pilot inpatient program (at one of its sites) for this medication. In this session, we will review this new medication and the Cleveland Clinic’s protocol for Zulresso.
Science and Pseudoscience of Mental Health Podcast: Episode 3 This past week, I had the great pleasure to talk with Dr. Kelly Brogan, a leading voice in natural approaches to women’s mental health. Dr. Brogan began her career as a conventional psychiatrist, but following the birth of her first child, she felt bereft of energy and mental clarity and was diagnosed with an autoimmune condition called Hashimoto’s Thyroiditis. Informed by her doctor that she had a chronic illness that would require a lifetime of medication, she launched her own research into her condition which catalyzed a profound paradigm shift in her understanding of health and wellness. Her research led her to Robert Whitaker’s Anatomy of an Epidemic after which time she permanently retired her prescription pad while turning towards natural interventions that support the body’s innate capacity to heal. With degrees from MIT and Weil Cornell Medical College, triple board certification in psychiatry, psychosomatic medicine and integrative holistic medicine, and direct experience practicing within the parameters of conventional psychiatry, Dr. Brogan is uniquely qualified to challenge the pseudoscience of the chemical imbalance theory and the drug regimens that it spawned. At the same time, her rigorous education conferred the investigative tools that enabled her to identify the scientific principles that support mental health. She focuses on the integrative nature of the gastrointestinal, immune, endocrine and nervous systems and their seamless communication with the ecosystem that resides within the body – the microbiome – and the ecosystem that surrounds us. This science is at the core of her thirty-day wellness protocol which she outlines in her New York Times bestselling book: A Mind of Your Own: The Truth About Depression and How Women Can Heal Their Bodies and reclaim Their Lives. Our conversation addressed Dr. Brogan’s grave concerns about the recent rollout of Zulresso (brexanolone), a drug specifically designed, and approved by the FDA for the treatment of Postpartum Depression. Drug trials that qualified Zulresso for FDA approval in fact revealed that its efficacy is weak at best, and not clinically significant. After 30 days, it was actually less effective than placebo. It requires an invasive 60-hour IV infusion with side effects that include sedation – sometimes to the point of loss of consciousness, separation of mother and infant, and cessation of breastfeeding. Women diagnosed with Postpartum Depression are suffering, but impactful interventions need to take into account the complex cultural, socioeconomic, personal and biological underpinnings of their symptoms. Masking symptoms with a drug that causes further disruption to their lives, lessens the likelihood that they will receive effective support. Dr. Brogan estimates that 80% of women who enter her practice having been diagnosed with Postpartum Depression have undetected and untreated thyroid conditions. We also discussed the reckless prescribing of SSRI antidepressants to one in four American women, many of whom are pregnant, and the long-term epigenetic consequences of SSRIs following prenatal exposure. Dr. Brogan shared her approach to tapering from SSRIs both during pregnancy and as part of her general treatment protocol. Our conversation came to a close with a fascinating exploration of the science that informs the relationship between meditation and mental health. Dr. Brogan shared the transformative impact that her own daily meditation practice has had on her capacity to cope with stress. To learn more about Dr. Brogan’s clinical work and research, you can visit her website. For other interviews in this series, click here. © Mad in America
In this week’s episode, John reviews some pharma breakthroughs—along with one major setback—and discusses the bold statement by the Department of Justice (DOJ) regarding the Affordable Care Act (ACA). Highlights include: The Department of Justice issued a letter stating that it agrees with a federal judge who struck down the entire ACA as unconstitutional. The FDA approved the first drug to treat postpartum depression: Sage Therapeutics’ Zulresso (brexanolone). Amarin Corp. presented updated results for its ongoing Vascepa (icosapent ethyl) clinical trial, REDUCE-IT, at the American College of Cardiology Annual Meeting. Biogen is scrapping its investigational treatment for Alzheimer’s disease, and is canceling its Phase III ENGAGE and EMERGE clinical trials. About Darwin Research Group Darwin Research Group Inc. provides advanced market intelligence and in-depth customer insights to health care executives, with a strategic focus on health care delivery systems and the global shift toward value-based care. Darwin’s client list includes forward-thinking biopharmaceutical and medical device companies, as well as health care providers, private equity, and venture capital firms. The company was founded in 2010 as Darwin Advisory Partners, LLC and is headquartered in Scottsdale, Ariz. with a satellite office in Princeton, N.J.
Bloomberg Businessweek Editor Joel and Bloomberg News Health Care Reporter Cynthia Koons discuss the trials and tribulations of postpartum depression drug Zulresso. Annie Massa, Bloomberg News Investing Reporter, talks about BlackRock buying risky software provider eFront. Charlie Bobrinskoy, Head of Investment Group at Ariel Investments, explains why Tiffany is a good company but not awlays a good stock. Megan Bent, Founder of Harbinger Ventures, discusses the state of funding for women entrepreneurs. Matthew Wadiak, Co-Founder of Blue Apron, talks about launching Cooks Venture a next generation food company saving the planet one chicken at a time. And we Drive to the Close with Charles Lemonides, Chief Investment Officer at ValueWorks. Hosts: Carol Massar and Jason Kelly. Producer: Paul Brennan
Bloomberg Businessweek Editor Joel and Bloomberg News Health Care Reporter Cynthia Koons discuss the trials and tribulations of postpartum depression drug Zulresso. Annie Massa, Bloomberg News Investing Reporter, talks about BlackRock buying risky software provider eFront. Charlie Bobrinskoy, Head of Investment Group at Ariel Investments, explains why Tiffany is a good company but not awlays a good stock. Megan Bent, Founder of Harbinger Ventures, discusses the state of funding for women entrepreneurs. Matthew Wadiak, Co-Founder of Blue Apron, talks about launching Cooks Venture a next generation food company saving the planet one chicken at a time. And we Drive to the Close with Charles Lemonides, Chief Investment Officer at ValueWorks. Hosts: Carol Massar and Jason Kelly. Producer: Paul Brennan Learn more about your ad-choices at https://www.iheartpodcastnetwork.com