Once-a-day pill for postnatal depression approved in US
By Susannah Hollywood
A new treatment for postnatal depression (PND) has been approved for use in the US which could bring significant improvements in both convenience and speed of action.
The newly licensed medication takes effect within days and is the first drug specifically for this condition which is available as a pill that can be taken at home.
Until now, treatments of this kind in the US have involved an inpatient hospital stay.
In the UK, there are currently no treatments available that are specific for postnatal depression. Instead, the condition is treated in the same way as other forms of depression, often with a combination of talking therapies, general antidepressants and self-help practices.
Some antidepressants, however, can take weeks or months to take effect, and talking therapies are not always accessible immediately.
This can result in a delay in symptom resolution, at a critical time in the life of a mother and baby.
In recent years in the US, a neuroactive steroid treatment has become available specifically for postnatal depression.
However, the drug is expensive and requires a hospital stay of several days for its administration by intravenous infusion.
Earlier this month, the US Food and Drug Administration (the regulatory body responsible for approving medications) approved a new treatment in this category available in pill form, which can be taken at home.
Zuranolone (sold under the trade name Zurzuvae) is taken once a day for 14 days. Clinical trial results have shown that it works rapidly, easing depression in many cases within 3 days.
The drug comes with a warning that it can cause drowsiness and dizziness, and a recommendation that patients taking the medication do not drive or operate heavy machinery within 12 hours of taking it.
Other side effects include diarrhoea, fatigue, cold-like symptoms and urinary tract infections. Severe side effects include increased suicidal thoughts and behaviour.
Zuranolone may also cause foetal harm and should not be taken during pregnancy, while contraceptives should be used during the period of taking it and for a week after.
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What is postnatal depression?
Postnatal depression is an episode of depressive illness experienced after giving birth. Symptoms are similar to those of depression experienced at other times of life, including sadness, low mood, guilt, worthlessness, lack of energy, lack of enjoyment in life, and withdrawal from contact with others. In severe cases, suicidal thoughts or thoughts of harming one’s baby may be involved.
These symptoms can be difficult to deal with and may affect a mother’s ability to look after herself or her child. They can also significantly disrupt the maternal-infant bonding process, which has the potential to put the child’s emotional and physical development at risk.
Postnatal depression (called postpartum depression in the US) is different from the ‘baby blues’ which are less significant mood changes experienced by many women after giving birth, usually lasting only a few weeks.
Postnatal depression is more severe and longer lasting, with the potential to be a serious and debilitating condition.
It is estimated that at least 1 in 10 women in the UK are affected by the condition within a year of giving birth.
A game changer in PND?
The price for the new treatment has not yet been released and so it is still unclear how many people with the condition in the US will be able to access it.
It is also not yet known how long lasting the effects of treatment will be — clinical trial results have shown that the benefits were maintained 4 weeks after finishing the 14-day treatment, but no data is currently available on longer term effects, and postnatal depression can last months or even years after giving birth.
Despite these unknowns, specialists in the field are excited about the benefits that this new treatment could bring.
“This will be a game changer” says Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia School of Medicine.
In many instances, a medicine's approval in one country results in its approval in another country soon after. However, as of this writing, there is no evidence that Biogen (the manufacturer of zuranolone) is planning to trial or release the drug in the UK market.
Zuranolone is expected to be available in the US later this year.
