Sage Therapeutics is expecting to win its first U.S. drug approval in March for an intravenous infusion to treat women with postpartum depression. On Monday, the biotech announced arguably better news: The next drug in Sage’s pipeline — a more convenient, once-daily pill — achieved its main antidepressive goals in a pivotal Phase 3 clinical trial of women suffering from the same disease.
Just as important, safety concerns about Sage’s oral drug, called SAGE-217, look to be allayed. None of the women enrolled in the clinical trial reported episodes of fainting or any loss of consciousness, Sage said.
Analysts expect Sage’s intravenous drug, called brexanolone, to amass peak annual revenue of around $300 million if approved to treat postpartum depression in March. SAGE-217, however, could generate billions of dollars in sales as an entirely new way to treat postpartum depression and major depressive disorder. That’s because SAGE-217 works much the same way as brexanolone, but it’s a pill taken once per day and thus doesn’t have practical limitations of its brexanolone’s 60-hour infusion.
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I might be old fashioned, but a drug where 2/3 of the therapeutic effect can be attributed to placebo effect (likewise for brexanolone infusion) leave me unimpressed.
And indeed, suggesting that postpartum depression is largely a psychological illness, rather than an organic one.
Surely, a good way to make money, though. And that’s all it matter, I guess.
Please, just don’t call it a scientific/medical achievement or breakthrough.
At least, this wannabe is a convenient pill.
There is a real need in severe PPD, as in any form of serious depression, but SAGE-217 falls short of rising to that particular challenge. While some efficacy was noted on day 3 against an uncharacteristically weak placebo response, said efficacy is in fact lower than placebo responses observed in prior trials in severe PPD (SAGE PhIII trial with Zulresso showed a 14 point placebo response in severe PPD & MRNS PhII trial with IV Ganaxolone showed a 12.7 point placebo response in severe PPD).
Rapid onset of efficacy is key in this patient population.
In moderate PPD, the key to the ‘blockbuster sales’ predicted here, SAGE have generated no data with 217. Furthermore, the drug’s safety profile is not as clean as suggested in this article: a marked increase in upper respiratory tract infections noted in the 217 arm cannot be explained by a GABAergic MOA – there appears to be off-target toxicity that needs to be explored further. If Zulresso’s LoC reporting is anything to go by, we may have to wait for another AdCom before 217’s safety profile is discussed candidly.
PPD is not “largely psychological” but it is likely to get better on its own with time as the new mother’s hormones regulate themselves. Most of the study participants got better whether or not they used the antidepressant.
It makes much more sense for women with PPD to try birth control to regulate their hormones before resorting to antidepressants with long-term side effects.