In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of postpartum depression (PPD).  SAGE-547, now called brexanolone, is an allosteric modulator of GABAA receptors.  Since that time, Sage Therapeutics has conducted three randomized controlled trials, enrolling a total of 247 women diagnosed with moderate to severe postpartum depression.

It is expected that the Food and Drug Administration (FDA) will soon approve brexanolone as an intravenous infusion for the treatment of PPD.  Sage Therapeutics plans to market the drug under the name ZULRESSO.  If approved, Sage plans to launch ZULRESSO in the United States in June 2019,

Brexanolone represents a novel approach to the treatment of postpartum mood disorders.  One of the most exciting things about brexanolone is the rapidity of the response — remission of depression within 24 to 48 hours!  Because antidepressants typically take 2-4 weeks to kick in, an antidepressant agent with rapid onset of action would be particularly appealing to women with severe PPD, especially those with women with suicidality.  

Zulresso will be a different kind of antidepressant.  No other antidepressants are administered intravenously, which will make the use of Zulresso more expensive and more cumbersome.  In previous trials, Zulresso was administered over 60 hours, which would require those treated with this medication to be hospitalized for 2 to 3 days.  

According to an article published today in MarketWatch, it is expected, the drug will likely be priced at $20,000 to $35,000 per treatment.  Presumably this figure does not include the cost of hospitalization and the fees associated with the hospital stay; that means Zulresso would be the most expensive antidepressant treatment on the market.  

Given the hefty cost of this medication, insurance companies may be reluctant to consider Zulresso as a first-line treatment for PPD.  As has been the case when other new antidepressants have entered the market, insurance companies may require a patient to try several other conventional antidepressants prior to pursuing treatment with Zulresso.

Still, it is exciting to have another antidepressant in our armamentarium.  

Ruta Nonacs, MD PhD