Brexanolone approved for treatment of postpartum depression: effective, but costly

The US FDA have approved brexanolone intravenous injection for treatment of postpartum depression. The proposition is that the drug will be available through a restricted programme administered by the sponsor, Sage Therapeutics. Brexanolone is administered as a continuous IV infusion over a total of 60 hours (2.5 days) but carries a risk of various adverse consequences such as sudden loss of consciousness, menaning that inpatient monitoring for excessive sedation, continuous pulse oximetry and supervision of interactions with their child(ren). Brexanolone was found in clinical trials to be superior to placebo for improvement of depressive symptoms by the end of the first infusion, and the improvement in depression was sustained at the end of the 30-day follow-up period. Common adverse reactions include sleepiness, dry mouth, loss of consciousness and flushing. In three clinical trials involving more than 200 women with postpartum depression, brexanolone was associated with a reduction in HAM-D total score, by an average of 17 points compared to just under 13 points observed with placebo. The drug is a formulation of the neurological steroid allopregnanolone and acts by modulating GABA receptors. The cost of a treatment course will be an eye-watering $US34,000 for a single treatment course, on top of the expenses associated with a hospital stay. The sponsor company is also progressing the development of an oral analogue. The development of a specific therapeutic intervention for this pressing issue is welcome, but questions remain about the cost of treatment. View the FDA announcement here