Sage gets a postpartum reprieve

Sage Therapeutics has finally had some good news: its Gaba-A modulator zuranolone produced a convincing win in Skylark, its pivotal postpartum depression study. The question is how much this will impress investors, who have their eye on the bigger use of major depressive disorder – and here there are still doubts about zuranolone’s approvability and commercial prospects. Sage and its partner Biogen have started a rolling submission in MDD, and plan a separate PPD filing early next year. One question is cost: Stifel analysts have speculated that Sage will price the drug for the larger MDD indication, although the company is staying tight-lipped for now. Sage estimates that around 500,000 women in the US have PPD, but only 28% of these are currently diagnosed; it hopes that an oral therapy will drive up this number. Sage already has a PPD drug in Zulresso, but that is given via a 60-hour infusion. The main downside in Skylark was a higher incidence of side effects like somnolence versus the lower-dose Robin trial, for arguably no additional clinical benefit. Sage reckons 50mg will be the go-to dose, with the option to reduce if required. The company’s stock climbed 4% this morning.

Flying high or wings clipped? Zuranolone's post-partum depression data
  Skylark (NCT04442503), 50mg Robin (NCT02978326), 30mg
HAMD-17 score change at… Placebo-adjusted difference p value Placebo-adjusted difference p value
 - day 3 -3.4 0.0008 -2.7 0.0255
 - day 15* -4.0 0.0007 -4.2 0.0029
 - day 28 -2.9 0.0203 Not given Not given
 - day 45 -3.5 0.0067 -4.1 0.0027
Somnolence 26.5% N/A 12.8% N/A
*Primary endpoint. Source: company releases &

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