Approximately 20 per cent of women experience postpartum depression (PPD) in North America which translates to about 76,000 women in Canada and 400,000 women in the United States.
PPD is a serious mood disorder in women that might be triggered by fluctuations in reproductive hormones. It can have negative effects for the mother and symptoms include frequent feelings of being sad, hopeless, guilty, anxious, irritable and/or angry.
Up until now, a doctor might prescribe a new mom an antidepressant which could take up to six weeks to take effect, if at all. She may have to switch to a different antidepressant and start the process all over again if the initial one does not work effectively.
A drug called brexanolone is hoped to be one that will change everything. The drug is a synthetic form of allopregnanolone, a hormone which increases in women during pregnancy then drops dramatically following child birth.
The decline in hormones following labour — including estrogen, progesterone, and in particular allopregnanolone — and its adverse effect on the brain’s neurotransmitters in some women is one of the main theories into the cause of postpartum depression.
Though the mechanism of action isn’t entirely known, providing brexanolone to women suffering from postpartum depression seems to work to help fill the gap created by the sudden loss in allopregnanolone.
In brexanolone trials, women with moderate to severe postpartum depression who were given an IV infusion over the course of 2.5 days revealed dramatic improvements within 24 hours that lasted for 30 days, (the length of the study).
The drug is currently under review by the U.S. Food and Drug Administration and if approved, could be on the market as early as 2019.
So, when is it coming to Canada?
No clear timelines have been set, however medical experts understand the importance of the potentially transformative medicine and say they are taking a thoughtful step-wise approach towards broad registration for the drug.
Overall Results so far have been Promising
Results of phase two findings for the drug involving 21 women were published last summer in The Lancet. Women less than six months postpartum with severe postpartum depression were randomly assigned to receive either brexanolone or a placebo treatment for 60 hours. Women were not permitted to breastfeed while receiving treatment.
Using the Hamilton Rating Scale for Depression (HAM-D), researchers found that in the women who received brexanolone, scores decreased by 21 points. In women who received the placebo, HAM-D scores decreased by eight points. Side effects included dizziness and drowsiness.
The results of two phase three brexanolone trials were recently released also and in the first trial of 100 women with moderate PPD, brexanolone was shown to reduce HAM-D scores by 14.2 points versus 12 points in women who were given a placebo.
In the second trial of 138 women with severe PPD, brexanolone was shown to reduce HAM-D scores by 19.9 points with a low dose of the drug and by 17.7 points with a high dose of the drug versus 14 points in women who were given a placebo.
Medical experts say that the drug, if approved and made available, could be life changing for women who suffer PPD, although there are other hurdles besides its effectiveness which include a high cost (it’s been estimated that the cost could amount to $15,000 to $20,000 per treatment) that need to be addressed.
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