FDA approves first treatment for post-partum depression

For Immediate Release: March 19, 2019

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The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient."

PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.

Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.

The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.

The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.

The FDA granted this application Priority Review and Breakthrough Therapy designation.

Approval of Zulresso was granted to Sage Therapeutics, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###</s>FDA approves first new drug developed for women with postpartum depression

The Food and Drug Administration on Tuesday approved brexanolone, the first drug specifically targeted to treat postpartum depression — the most common complication of childbirth. Yet it’s a condition that often goes untreated because new mothers fear being stigmatized if they report symptoms.

Brexanolone is the first drug developed by and approved from Sage Therapeutics (SAGE). The Cambridge, Mass.-based biotech company will market the new medicine under the brand name Zulresso.</s>The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression — a debilitating condition that affects hundreds of thousands of women a year in the United States.

The disorder, which begins during pregnancy or within a month of childbirth, is characterized by feelings of worthlessness or guilt, or thoughts of suicide and is far more severe than the common “baby blues.” The condition can interfere with a mother’s ability to bond with an infant, which can affect the baby’s development. An estimated 400,000 women in the United States each year suffer from postpartum depression.

The newly approved drug, called brexanolone, will be marketed under the name Zulresso. Its manufacturer, Sage Therapeutics in Cambridge, Mass., said a course of treatment would probably cost $20,000 to $35,000.

Tiffany Farchione, acting director of the psychiatry products division at FDA, said in a statement that the medication represented “an important new treatment option” for a potentially life-threatening condition. The drug, she said, is administered intravenously for 60 continuous hours. The approval requires that it be administered under strict safety conditions because of concerns it can cause “excessive sedation and sudden loss of consciousness.”

The drug will be available to patients only through a restricted distribution program at certified facilities — such as doctors’ offices or clinics — where health-care providers can carefully monitor the patient. It will carry a “boxed warning,” which is the strongest warning required by the FDA.

The FDA-approved label says data from a study in which a dozen women who were breast-feeding received the drug showed that the medication is transferred to breast milk in nursing mothers. However, the amount that is passed to the infant is low, and available data “do not suggest a significant risk of adverse reactions to breastfed infants from exposure to Zulresso.”

The FDA said the drug’s efficacy was shown in two clinical studies in which participants received either the medication or a placebo and were then followed for four weeks.

Experts called the drug a major advance for a serious illness that does not get enough attention. “We don’t have any treatments that are anywhere near this effective,” said Jess Fiedorowicz, a psychiatrist at the University of Iowa and a member of an FDA advisory panel that recommended agency approval of the drug. “So this is groundbreaking in that regard.”

Women diagnosed with postpartum depression are currently treated with antidepressants and psychotherapy, but the drugs take four to eight weeks to be fully effective and generally have only a small to moderate impact. The new drug, by contrast, takes effect quickly and lasts at least 30 days, according to clinical studies.

Still, Fiedorowicz said, the cost and method of administration could prevent women from getting it.

Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina at Chapel Hill, who led the clinical trials for the drug, said the medication is such an improvement over current therapies that she doubts the IV administration will discourage its use. She noted that postpartum depression, one of the most common complications of childbirth, is “underdiagnosed and neglected,” and that suicide is a major cause of maternal death.

“For women suffering, you can say, ‘You can come in and be treated and in 2.5 days it can go away, and not come back,’ " she said. In clinical trials, she added, the IV administration did not prevent women from getting the drug.

The main component of drug is allopregnanolone, “a breakdown product” of the hormone progesterone that affects the GABA neurotransmitters, which have a role in mood regulation, Meltzer-Brody said. She added that the exact mechanism of action is unknown.

Sage is developing another drug to treat postpartum depression and major depressive disorder that would be administered as a once-daily pill. The medication recently showed good results in a Phase 3 clinical trial. If approved, it could be a blockbuster, some industry analysts say.

The FDA’s advisory committee recommended approval of brexanolone in early November, but the agency delayed the green light to evaluate concerns about the small number of women who lost consciousness while receiving the drug. The agency’s safety requirements are designed to deal with those safety concerns.

Anna Glezer, a psychiatrist at the University of California at San Francisco, said she was encouraged to see an entirely new approach to medication for depression and, in particular, a product aimed specifically at women’s mental health.

She said mild to moderate cases can be missed because the fatigue and sleeplessness that accompany the arrival of a new baby are also some of the physical symptoms of depression. In her clinical practice, she said, she asks women: “Can you sleep when your baby is sleeping? Is your energy lower given how much sleep you’re getting?”

Postpartum depression also is frequently accompanied by anxiety, she said.

Given the way the drug will be administered, Glezer said she expects it to be used mainly on the most severe cases, especially women whose postpartum depression requires hospitalization.

The FDA action is the second important approval involving depression this year. Earlier this month, in biggest advance for depression in years, the FDA approved esketamine, also called Spravato, for people with major depression who have not responded to other treatments.

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Health advocates worry about an FDA without Scott Gottlieb</s>The Food and Drug Administration has approved the first drug specifically designed to treat postpartum depression.</s>Sage Therapeutics says the medication brexanolone, whose trade name is Zulresso, will be available in late June in the US

WASHINGTON, USA – US authorities on Tuesday, March 19, approved the first medication designed specifically to treat post-partum depression, an illness that affects about one in nine new American mothers.

The drug is called brexanolone from a company called Sage Therapeutics and one advantage is that it works quickly, in two days, whereas traditional antidepressants can take weeks or months to kick in.

The drug's trade name is Zulresso. It has been approved by the Food and Drug Administration (FDA).

But it needs to be administered intravenously in a hospital over the course of 60 hours because of the risk of fainting that was observed in some women during clinical tests.

"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child," said Tiffany Farchione, acting director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research.

"This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," she added.

The most common secondary effects include drowsiness and dryness of the mouth.

Sage Therapeutics said the medication will be available in late June in the US.

US media say the treatment will cost $34,000 a year for people without health insurance. Insurers get it at a discounted rate. The full rate is without the cost of the hospital stay for administering it.

The Centers for Disease Control and Prevention say 11.5% of new mothers suffered from post partum depression in 2012. – Rappler.com</s>The Food and Drug Administration approved the first drug specifically for the treatment of postpartum depression Tuesday.

The drug, which is administered via an intravenous drip, reportedly works within 48 hours, providing near immediate relief to women experiencing symptoms, according to the New York

Postpartum depression has historically been treated with counseling or general antidepressants, which can take weeks to kick in or may not work at all.

The newly-approved drug, brexanolone, will be marketed as Zulresso. The treatment will be offered only as an in-patient option at certified medical centers because it can cause sudden loss of consciousness, according to an F.D.A. press release.

A pill version of the treatment could make the drug more widely accessible, and is currently undergoing clinical trials, according to the

Zulresso might cost up to $34,000 per patient, excluding the costs associated with several days stay in a medical center. Insurance companies are currently evaluating Zulresso, but Sage Therapeutics, the manufacturer, told the that it expects insurers to cover the treatment.

The F.D.A. approved the new treatment after clinical studies showed that patients who received Zulresso have less depressive symptoms than patients given a placebo infusion.

Brexanolone is synthetic form of allopregnanolone, which is a hormone produced by progesterone in the brain that can help alleviate depression, Dr. Samantha Meltzer-Brody, who led the clinical studies, told the .

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” said Dr. Tiffany Farchione, the F.D.A.’s acting director of the Division of Psychiatry Products.

Postpartum depression is a mood disorder that can affect women after childbirth. The symptoms, including extreme sadness, anxiety and exhaustion, may interfere with a new mother’s ability to care for herself or her baby. New fathers can also experience the condition.

Up to 1 in 7 women experience postpartum depression after childbirth, according to the American Psychological Association.</s>March 20 (UPI) -- U.S. regulators have approved the first medication designed specifically for women with postpartum depression, which the drug maker calls a breakthrough treatment.

The Food and Drug Administration approved Zulresso (brexanolone) on Tuesday for intravenous injection and to be administered through a restricted program, the agency said in a statement.

Postpartum depression is a major depressive episode for women that happens after childbirth -- although initial symptoms can start during pregnancy. It's characterized by sadness, loss of interest in activities that may lead to cognitive impairment and suicidal impulses.

"Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond," said Dr. Tiffany Farchione of the FDA Center for Drug Evaluation and Research. "This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option."

Farchione said Zulresso must be managed due to the risk of excessive sedation and sudden loss of consciousness.

The new treatment is costly -- averaging $34,000 per patient. The cost doesn't include hospital costs, since a medical facility is required to dispense the drug over a 60-hour period. The drug's relief lasts for about a month, Sage Therapeutics, the drug's manufacturer, said.

Sage called the new drug a "game-changing approach" to treating postpartum depression.

"This brings up a lot of very complex public health issues," Dr. Kimberly Yonkers, a professor of psychiatry, obstetrics, gynecology and reproductive sciences at Yale, told The New York Times.

"It may be worth it, if somebody has been treatment-resistant or they can't wait the two to four weeks for an antidepressant to kick in. Depression can be pretty miserable."</s>US approves ketamine-like nasal spray as first new antidepressant med in decades

The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth.

The agency on Tuesday approved Sage Therapeutics' Zulresso, an IV drug given over two and a half days.

Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion center. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan.

In a company-funded study of new mothers with moderate or severe postpartum depression, half the women given Zulresso had depression end within two and a half days, about double the rate of those in a comparison group given dummy treatments.

Postpartum depression affects about 400,000 American women a year. It often ends on its own within a couple weeks, but it can continue for months or even years. It can be treated with antidepressants, which can take six to eight weeks to work and don't help everyone, or with counseling.

"Postpartum depression is a serious condition that, when severe, can be life-threatening," Dr. Tiffany Farchione of FDA's Division of Psychiatry Products said in a statement. "Women may experience thoughts about harming themselves or harming their child,"

Zulresso's active ingredient, brexanolone, mimics a derivative of the naturally occurring hormone progesterone, levels of which can plunge after childbirth. The infusion helps restore normal levels and emotions, according to Sage Chief Executive Dr. Jeff Jonas.

The drug's most common side effects were sleepiness, dizziness and headaches. A few women had more-serious problems, such as fainting and loss of consciousness.

Because those risks could result in injury, the FDA said it is restricting Zulresso's use to certified health care facilities where patients can be closely monitored throughout the infusion.

Zulresso appears safe for breastfeeding, said Dr. Kimberly Yonkers, a psychiatrist specializing in postpartum depression who heads Yale Medical School's Center for Wellbeing of Women and Mothers.

She expects the drug will be used to treat serious cases and patients not helped by antidepressants.

"It's going to depend on patient willingness to go into an infusion center and insurers being willing to pay for this," Yonkers added.

Sage plans to begin selling the drug in late June.

It's developing a second, similar treatment in pill form, and Marinus Pharmaceuticals is testing both a pill and IV therapy.</s>The first drug for women suffering postpartum depression received federal approval on Tuesday, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy.

The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which can take two to four weeks to have an effect, if they work at all.

Experts say the new treatment will provide immediate relief for mothers whose depression keeps them from providing their babies with the care, bonding and nurturing that is crucial for healthy development. As many as 1 in 7 American women experience depression during or after pregnancy.

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”

There are limitations to the new drug, brexanolone, which will be marketed as Zulresso. It is delivered by infusion over 60 hours, during which a new mother must remain in a certified medical center, under supervision should she get dizzy or faint, as several patients did in clinical trials.

The infusion will be expensive, averaging $34,000 per patient before discounts, according to Sage Therapeutics, the manufacturer. That does not include the costs of staying in a medical center for 2½ days. Company officials say they expect that insurers will cover the treatment; insurers said this week that they are evaluating the drug.

A pill made with a similar molecule, which would be much more accessible and easier for patients, is showing promise in its clinical trials and would be submitted for approval in a couple of years if the results are good, according to Sage.

The infusion is to be administered just once, and patients may also take standard antidepressants. Clinical trials of the drug, all sponsored by Sage, found that it produced a steeper decrease in symptoms in women with severe and moderate postpartum depression than a similar placebo infusion.</s>The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression — a debilitating condition that affects hundreds of thousands of women a year in the United States. The disorder, which begins during pregnancy or within a month of childbirth, is characterized by feelings of worthlessness or guilt, or thoughts of suicide and is far more severe than the common “baby blues.” The condition can interfere with a mother’s ability to bond with an infant, which can affect the baby’s development. An estimated 400,000 women in the United States each year suffer from postpartum depression.

The newly approved drug, called brexanolone, will be marketed under the name Zulresso. Its manufacturer, Sage Therapeutics in Cambridge, Massachusetts, said the drug would likely cost $20,000 (U.S.) to $35,000 for a course of treatment. The medication must be administered intravenously for 60 continuous hours and — under an FDA safety program that accompanied its approval — under the supervision of a health care professional, in a doctor’s office or a clinic, for example. Experts called the drug a major advance for a serious illness that does not get enough attention. “We don’t have any treatments that are anywhere near this effective,” said Jess Fiedorowicz, a psychiatrist at the University of Iowa and a member of an FDA advisory panel that recommended agency approval of the drug. “So this is groundbreaking in that regard.”

Still, said Fiedorowicz, the cost and method of administration could prevent women from getting it. Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina, Chapel Hill, who led the clinical trials for the drug, said the medication is such an improvement over current therapies that she doubts the IV administration will discourage its use. She noted postpartum depression, one of the most common complications of childbirth, is “under-diagnosed and neglected,” and that suicide is a major cause of maternal death.

“For women suffering, you can say, ‘You can come in and be treated and in 2.5 days it can go away, and not come back,” she said. In clinical trials, she added, the IV administration did not prevent women from getting the drug. The main component of drug is allopregnanolone, “a breakdown product” of the hormone progesterone that affects the GABA neurotransmitters, which have a role in mood regulation, said Meltzer-Brody. She added that the exact mechanism of action is unknown. Sage is developing another drug to treat postpartum depression and major depressive disorder that would be administered as a once-daily pill. The medication recently showed good results in a phase 3 clinical trial. If approved, it could be a blockbuster, some industry analysts say. The FDA’s advisory committee recommended approval of brexanolone in early November, but the agency delayed the green light to evaluate a safety concern: A small number of women who received the drug lost consciousness. That problem is easily solved by lowering the dose, said Meltzer-Brody. But it is the reason why the agency is requiring that the drug be given under the supervision of a health professional’s supervision. The approval is the second important one involving depression this year. Earlier this month, in biggest advance for depression in years, the FDA approved esketamine, also called Spravato, for people with major depression who have not responded to other treatments.
The U.S. Food and Drug Administration approves Sage Therapeutics' Zulresso, also known as allopregnanolone or brexanolone, for treatment of postpartum depression. It is the first drug approved to specifically target the disease, which is the most common complication of childbirth.