In the US, the FDA approved a drug for post-natal depression – Brexanolone – for the first time. The therapy, the agency’s statement explains, has shown in clinical tests to be able to reduce symptoms for at least 30 days.
The drug, the FDA press release explains, is administered in the hospital by intravenous infusion and lasts 60 hours, always under medical supervision due to the risk of losing consciousness.
“Postpartum depression is a very serious problem that, in severe cases, puts life at risk – underlines Tiffany Farchione from the FDA – Women may have self-injuring or threatening thoughts about the child. This approval marks the first time a drug has been specifically approved to treat post-natal depression, and is an important treatment option.”
The drug is also being approved by Ema, the manufacturer reports on its website, with the European agency that awarded it the ‘Prime’ status, which should speed up the process. The first drug approved in the US specifically for post-partum depression represents a decisive turning point in the lives of millions of women in the world affected by the disorder (about one in nine new mothers) that can also occur in severe form, endangering the life of woman and child and that to date did not have resolving treatment.
This was reported by Graziano Pinna, a neuroscientist and psychiatrist at the University of Illinois in Chicago, commenting on the FDA’s ‘brexanolone’ ok, a slightly modified form of a ‘natural tranquilliser’ produced in the brain called “allopregnanolone”. The disorder that, underlines Pinna, if not treated can last months and even years, is caused by the rapid decrease, which occurs immediately after birth, of steroid hormones such as progesterone but above all of allopregnanolone. “My laboratory – Pinna reports – during years of research in this field has shown for the first time that this molecule, also produced in the brain, plays an important physiological role as an endogenous tranquilliser“. The Brexanolone assures the new mother to restore the function that is lacking for the drastic decrease of the endogenous levels of steroids, continues Pinna.
“The advantages of this treatment – the expert points out – are enormous, in fact, not only the antidepressant effects take place a few hours after administration, but they are also long-lasting, in fact the symptoms do not recur in 94% of the patients treated. This is a big step forward compared to the antidepressant treatments used so far that are of low efficacy, begin to work after weeks and are associated with relapses. The Brexanolone – concludes Pinna – represents one of the first antidepressant drugs of new generation with fast action with future applications also for the major depression and probably to other mood disorders such as post-traumatic stress disorder”.