KOL Views Preview: Will physicians use Sage, Biogen’s zuranolone in MDD?

Zuranolone hit its statistical marks in the Phase III WATERFALL trial to treat major depressive disorder (MDD) last week, however, the magnitude of benefit raised questions about whether Sage Therapeutics and Biogen will be able to turn the allosteric GABAA receptor modulator into a commercial success.

To provide FirstWord readers with rapid feedback on where zuranolone will fit into the MDD treatment armamentarium, we are hosting an expert call with a key opinion leader (KOL) this week.

Key topics that will be discussed during the call include, among other things… top-line thoughts on the top-line WATERFALL results; how concerned are you about the safety of 50 mg zuranolone given the notable uptick in rates of somnolence, dizziness and headache versus the previous MOUNTAIN study that tested a 30 mg dose; do you think tolerability will be an issue with zuranolone; are how impressed are you by zuranolone’s efficacy, including a 14.1-point improvement on HAM-D scores after 15 days that is cut to 1.7 points after adjusting for placebo; how likely is it that an unexpectedly large placebo response (12.3-point improvement on HAM-D) is masking some of zuranolone’s activity; do you subscribe to a 3.0-point improvement threshold on HAM-D scores being relevant and in your opinion does zuranolone offer a clinically meaningful benefit in MDD; is Sage’s argument persuasive that patients retained 86% of the benefit out to 42 days given the fact that placebo patients retained as much if not more benefit; how would you characterise zuranolone’s risk/benefit profile; do you think that zuranolone will be approved based on the WATERFALL results; what marketed MDD drugs is zuranolone likely to compete with and how does it stack up; where do you see it fitting into the treatment algorithm; are there certain patient populations where this might be more ideal; what are going to be some of the biggest hurdles to adoption; and to what proportion of patients could you foresee prescribing a therapy like zuranolone?

Ask the expert!

Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to zuranolone and the MDD market.

We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.

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As always, FirstWord Pharma would very much like to receive your feedback and suggestions.

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