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Zuranolone

All articles tagged with #zuranolone

health1 year ago•2 min saved

"First Pill for Postpartum Depression Now Available and Effective"

Zuranolone, the first pill for postpartum depression, has been approved and is now being prescribed by psychiatrists. This condition, affecting up to 1 in 5 women, can lead to severe consequences like suicide and developmental delays in infants. Previously, treatment options were limited to intravenous injections with significant side effects. Early reports indicate that Zuranolone shows promise, with some patients experiencing improvements within days, though its long-term efficacy remains uncertain.

via Interesting Engineering|

#fda-approval #health #mental-health

health1 year ago•6 min saved

"First Pill for Postpartum Depression Reaches Patients, Shows Promise"

The first pill for postpartum depression, zuranolone, is now available to patients and showing promising results. Approved by the FDA in August, the drug acts quickly and can be taken at home, offering a significant improvement over previous treatments. Despite some concerns about side effects and insurance hurdles, doctors are optimistic about its potential to transform postpartum depression care.

via Yahoo! Voices|

#fda-approval #health #mental-health

health1 year ago•6 min saved

"First Pill for Postpartum Depression Offers New Hope for Mothers"

via NBC News|

#fda-approval #health #mental-health

health1 year ago•5 min saved

"Insurers' Response to $16,000 Postpartum Depression Drug"

The new postpartum depression drug zuranolone, priced at $15,900 for a 14-day regimen, faces uncertainty in coverage by private health insurers, with most yet to publish criteria for when they will cover it. Advocates are concerned about potential restrictive policies, such as requiring patients to try and fail standard antidepressants before being eligible for zuranolone. Kaiser Permanente's previous stringent criteria for its predecessor, brexanolone, led to regulatory actions and policy changes, offering hope for more patient-friendly policies for zuranolone. Insurers' policies for zuranolone will be written in a shifting regulatory environment around mental health treatment, with increased scrutiny on compliance with mental health parity laws.

via CNN|

#health #insurance-coverage #kaiser-permanente

health1 year ago•6 min saved

"Postpartum Depression Pill Faces Uncertain Insurance Coverage"

The new prescription pill zuranolone for postpartum depression has hit the market, but most private health insurers have yet to publish coverage criteria, potentially limiting its use. Advocates are concerned about insurers' restrictive policies, such as requiring patients to try and fail on standard antidepressants before covering zuranolone. California's largest insurer, Kaiser Permanente, faced criticism for its rigorous criteria for the IV form of the drug, brexanolone, but has since revised its guidelines. With the regulatory environment around mental health treatment shifting, advocates hope for more patient-friendly policies and increased access to zuranolone.

via NPR|

#health #insurance-coverage #kaiser-permanente

health2 years ago•5 min saved

"FDA Approves Zuranolone: A Breakthrough Pill for Postpartum Depression"

The US FDA has approved the first pill specifically designed to treat postpartum depression, providing a more convenient and fast-acting medication option for severe cases. Postpartum depression affects approximately one in seven women who have given birth, but 50% of cases go undiagnosed due to gaps in screening and reporting. The newly approved pill, zuranolone, works by improving levels of allopregnanolone, a neuroactive steroid that can decrease after pregnancy. It has been found to take effect within three days and have a lasting positive impact. However, experts caution that the medication may not be suitable for mild to moderate cases and stress the importance of addressing structural factors and utilizing other tools like therapy.

via Vox.com|

#fda-approval #health #mental-health

business2 years ago•1 min saved

Sage Therapeutics Faces Stock Plunge and FDA Approval Setback

Sage Therapeutics' stock plummeted by 49% in premarket trading after the FDA approved its zuranolone treatment for postpartum depression but not for major depressive disorder (MDD). The FDA's approval makes zuranolone the first and only oral treatment for postpartum depression, a condition that affects one in eight new mothers in the US. Sage is currently reviewing the FDA's feedback and considering its next steps, including resource allocation and a workforce reorganization. CEO Barry Greene stated that the company plans to provide more details and next steps before the end of the third quarter. Biogen, which co-developed zuranolone, also saw a decline in its stock.

via MarketWatch|

#business #fda #major-depressive-disorder

health2 years ago•2 min saved

FDA Approves Zuranolone: A Breakthrough Pill for Postpartum Depression

The FDA has approved zuranolone, an oral pill manufactured by Sage Therapeutics and Biogen, as the first medication to treat postpartum depression. Zuranolone works by bonding to GABA receptors in the brain, resetting neurotransmitters that are unbalanced in people with depression and other mood disorders. Clinical trials showed significant improvement in depressive symptoms after 15 days of treatment. The drug is expected to provide rapid reduction of symptoms within three days. It is estimated that around 500,000 women in the U.S. experience postpartum depression each year.

via Forbes|

#fda #health #mental-health

health2 years ago•8 min saved

FDA Approves Zurzuvae: First Oral Pill for Postpartum Depression in the US

The US Food and Drug Administration (FDA) has approved zuranolone, the first oral pill specifically for postpartum depression in the United States. Sold under the brand name Zurzuvae, the once-daily pill is taken over a 14-day course. Postpartum depression affects about 1 in 7 new mothers and can have serious consequences for both the mother and child. The medication, which is a version of a naturally occurring substance in the body, has shown rapid relief of symptoms in clinical trials. However, some experts raise concerns about its use for mild to moderate depression and emphasize the importance of psychotherapy and addressing social determinants of health.

via CNN|

#fda #health #medication

health2 years ago•4 min saved

FDA Approves Groundbreaking Pill for Postpartum Depression Treatment

The FDA has approved zuranolone, the first oral treatment for postpartum depression. Branded as Zurzuvae, the once-a-day pill is meant to be taken for two weeks and has shown rapid improvement in depression symptoms. Postpartum depression affects an estimated 15% of women after childbirth and can last for months or even years. Previously, the only approved option was an IV infusion. Zuranolone works by rebalancing dysregulated neuronal networks in the brain. The drug carries a boxed warning for side effects such as drowsiness and dizziness, and a risk of suicidal thoughts. It will need to clear a 90-day DEA scheduling process before entering the market. The FDA only approved zuranolone for postpartum depression, not major depressive disorder, citing a lack of evidence.

via CBS News|

#fda #health #mental-health

health2 years ago•2 min saved

"FDA Greenlights Zurzuvae: First-Ever Pill for Postpartum Depression"

The FDA has approved the first oral medication, zuranolone (brand name Zurzuvae), to treat postpartum depression. Postpartum depression affects about 1 in 7 women following childbirth and can have serious consequences for both the mother and child. Previously, the only FDA-approved treatment was an IV injection, but the new pill can be taken at home. Zurzuvae acts quickly, providing relief during the crucial bonding period after childbirth. However, researchers caution that postpartum depression has multiple underlying causes and that social support, longer maternity leave, flexible work schedules, and universal child care are also needed. The medication's side effects include drowsiness and dizziness.

via The Washington Post|

#fda #health #medication

health2 years ago•3 min saved

"Breakthrough Postpartum Depression Pill Nears Approval"

A pill called Zuranolone has shown promising results in clinical trials for treating postpartum depression (PPD) and could be approved by the FDA as early as next week. The medication, taken for two weeks, targets GABA receptors in the brain using a substance called neurosteroid. In a study of 196 mothers with PPD, those taking Zuranolone experienced significant improvements in depressive symptoms compared to those on a placebo. Side effects were minimal, but long-term effects and impact on breastfeeding remain unknown. If approved, Zuranolone would be the first pill specifically for PPD, as the only current treatment is administered through an IV.

via New York Post |

#clinical-trials #fda-approval #health

health2 years ago•2 min saved

Breakthrough Postpartum Depression Pill Shows Significant Promise

A phase III clinical trial conducted by Sage Therapeutics and Biogen has shown promising results for a new drug called Zuranolone, designed to relieve symptoms of postpartum depression. The drug, taken in pill form for multiple days, works by balancing the firing of neurons involved in mood and behavior. In the study, women who received the drug reported significant improvements in their symptoms, while those who received a placebo also saw some improvement. The FDA is expected to decide whether to approve the drug by August 5.

via Medical Xpress|

#clinical-trial #health #mood-disorder

health2 years ago•2 min saved

New trial data reveals positive effects of postpartum depression pill

A late-stage study published in The American Journal of Psychiatry has shown that the pill zuranolone led to significant improvements in depression symptoms for mothers experiencing postpartum depression. The study, funded by Sage Therapeutics and Biogen, split 196 mothers into two groups, with half receiving zuranolone and half receiving placebo pills for two weeks. The mothers taking zuranolone reported better improvements in their depression symptoms compared to those on placebo, and these improvements were still observed four and six weeks later. If approved, zuranolone would be the first pill specifically approved for postpartum depression treatment, offering a new option for women struggling with this condition. However, the long-term effects and impact on breastfeeding remain unknown. Experts emphasize the importance of seeking medical care for depression and addressing the stigma surrounding postpartum depression.

via GMA|

#fda-approval #health #mental-health

health2 years ago•5 min saved

"Promising Postpartum Depression Pill Nears FDA Approval with Strong Trial Results"

Zuranolone, a postpartum depression medication, has been granted "priority review" by the FDA and is currently being considered for approval. In a phase three trial, women who took a daily 50-milligram dose of zuranolone for 14 days showed significant improvements in depressive symptoms compared to those who received a placebo. The improvements were still reported 28 and 45 days later. Side effects of zuranolone included drowsiness, dizziness, and sedation, but none were severe. The medication is seen as a potential quick and effective treatment for postpartum depression, particularly for women who face barriers to accessing long-term treatments. However, further studies are needed to assess the long-term impact and its effects on breastfeeding mothers and patient-child interaction.

via KSL.com|

#clinical-trial #fda-approval #health