The Food and Drug Administration (FDA) 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 characterised 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 or 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 a course of treatment would likely cost $20,000 to $35,000 (£15,000-£26,500).
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.
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Qatar Hospital, Karachi Hospital, Pakistan: Naseem’s baby was deliveredon 6 August 2007. Despite conditionswhich force six pregnant womento share four beds, Qatar Hospitalis one of the better places to givebirth in Pakistan. In a nearbymaternity ward, one women hadjust lost her eleventh child
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Malalai Hospital, Kabul,Afghanistan: Mariam, 20, in labour withher first baby. She was dragged by thehair from the delivery room to makespace for other women who werecloser to giving birth. In acute pain,she finally delivered a baby with blackboils on its body. Doctors suspected itto be a simple cancer and referred thebaby to Indira Gandhi Hospital.Mariam is recovering
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Orangi District, Karachi, Pakistan: Nabila, 32, is pregnant with her eight child. All her deliveries have taken place at home, with the assistance of the ‘dai’ who induces her labours using unknown methods. Three babies have died during childbirth and Nabila has never had an antenatal check-up
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Faizabad Hospital: Badakshan Province, Afghanistan: Mastana, 23, first became pregnant at 17 and now has three children. She is pregnant again, suffering from virginal discharge and abdominal pain, and has travelled for two days to reach the hospital from the Kuffab district where she lives
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Qatar Hospital serves the people of the Orangi District, a sprawling urban slum of three-and-a-half million people
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Chowkmagu Village, Panchthar District, Nepal: Kali, 45, is brought to the local hospital on a stretcher. She had not known she was pregnant and suffered a complete cervical prolapse. The family thought the baby’s head had come out and she stayed at home like that for three days before the family decided to take her to hospital. There it was confirmed that Kali was 32 weeks pregnant, but also that she had cancer of the cervix. There was not foetal heartbeat
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Panchthar District Hospital, Phidim, Nepal: Dhan, 22, mid-labour. This is her first pregnancy, she has had no antenatal check-ups, has high blood pressure and a history of drinking. Dhan consumed alcohol the morning she was admitted to hospital, which followed a one-hour trek by stretcher from her home. The baby is born with symptoms of asphyxia and Foetal Alcohol Syndrome
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Qatar Hospital, Karachi Hospital, Pakistan: Naseem’s baby was deliveredon 6 August 2007. Despite conditionswhich force six pregnant womento share four beds, Qatar Hospitalis one of the better places to givebirth in Pakistan. In a nearbymaternity ward, one women hadjust lost her eleventh child
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Malalai Hospital, Kabul,Afghanistan: Mariam, 20, in labour withher first baby. She was dragged by thehair from the delivery room to makespace for other women who werecloser to giving birth. In acute pain,she finally delivered a baby with blackboils on its body. Doctors suspected itto be a simple cancer and referred thebaby to Indira Gandhi Hospital.Mariam is recovering
3/8
Orangi District, Karachi, Pakistan: Nabila, 32, is pregnant with her eight child. All her deliveries have taken place at home, with the assistance of the ‘dai’ who induces her labours using unknown methods. Three babies have died during childbirth and Nabila has never had an antenatal check-up
4/8
Faizabad Hospital: Badakshan Province, Afghanistan: Mastana, 23, first became pregnant at 17 and now has three children. She is pregnant again, suffering from virginal discharge and abdominal pain, and has travelled for two days to reach the hospital from the Kuffab district where she lives
5/8
Qatar Hospital serves the people of the Orangi District, a sprawling urban slum of three-and-a-half million people
6/8
Chowkmagu Village, Panchthar District, Nepal: Kali, 45, is brought to the local hospital on a stretcher. She had not known she was pregnant and suffered a complete cervical prolapse. The family thought the baby’s head had come out and she stayed at home like that for three days before the family decided to take her to hospital. There it was confirmed that Kali was 32 weeks pregnant, but also that she had cancer of the cervix. There was not foetal heartbeat
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Panchthar District Hospital, Phidim, Nepal: Dhan, 22, mid-labour. This is her first pregnancy, she has had no antenatal check-ups, has high blood pressure and a history of drinking. Dhan consumed alcohol the morning she was admitted to hospital, which followed a one-hour trek by stretcher from her home. The baby is born with symptoms of asphyxia and Foetal Alcohol Syndrome
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The drug, ms Farchione 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 breastfeeding received the drug showed that the medication is transferred to breast milk in nursing mothers. However, the amount that is passed on 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 ground-breaking in that regard.”
Women diagnosed with postpartum depression currently are 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, said Ms 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 Ms 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 three 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, 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?”
Post-partum depression also is frequently accompanied by anxiety, she said.
Given the way the drug will be administered, Ms Glezer said she expects it to be used mainly on the most severe cases, especially women whose post-partum depression requires hospitalisation.
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.
The Washington Post
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