Sage-Biogen drug improves symptoms in postpartum depression study

Sage Therapeutics Inc and Biogen’s experimental drug improved symptoms of postpartum depression after 15 days in a late-stage study, the companies said yesterday.

The drug, Zuranolone, also reduced depression severity as early as the third day of treatment compared with placebo in the study conducted among 200 adult women.

Zuranolone, Sage’s most advanced drug candidate, is being developed for the treatment of major depressive disorder as well. It improved depression symptoms in two late-stage studies, but there have been concerns about its effectiveness and durability.

Analysts have said the near-term durability of the oral drug would be important for its broader commercial success and expressed concerns about whether its data in MDD would limit market opportunity.

While yesterday’s announcement bodes well for Zuranolone, postpartum depression is a smaller market opportunity than major depressive disorder, said Robyn Karnauskas, analyst, Truist Securities.

The target population for major depressive disorder is higher than postpartum depression, but the latter’s “competitive intensity is much lower,” Jeff Jonas, Chief Innovation Officer, Sage, told Reuters.

A previous late-stage study testing a lower dose of Zuranolone for postpartum depression had also met the main goal, according to the company.

Sage signed a deal worth up to $1.5 billion with Biogen in 2020 to develop Zuranolone along with another experimental drug.

The companies started submitting data on the drug to the US health regulator for the treatment of major depressive disorder earlier this month and expect to complete the marketing application in the second half of the year.

They expect to file for the drug’s approval for postpartum depression early next year.

Edits by EP News Bureau