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Zuranolone Launch Requires Sage To Shift The Way Doctors Treat Depression

US Approval Decision Expected By 5 August

 
• By Mandy Jackson

CEO Barry Greene and team spoke with Scrip about Sage and Biogen’s focus on short-term, episodic dosing, and said doctors and payers – pending zuranolone’s approval – are responding to the sales pitch.  

Panic attack in public place; depressed sad person surrounded by people walking in busy street.
Zuranolone has shown efficacy in depressed patients who also have anxiety • Source: Shutterstock

The clinical trials are completed, a new drug application has been accepted, and the US Food and Drug Administration has set a 5 August action date for deciding whether to approve Sage Therapeutics, Inc.’s zuranolone for major depressive disorder (MDD) and postpartum depression (PPD). And while checking those tasks off its to-do list with partner Biogen, Inc., the companies have been working on a commercial strategy they are eager to roll out around the end of the year that will require a new way of thinking about how to treat depression.

Even with a summertime approval, if all goes to plan, it will be late 2023 before zuranolone is available for patients because the oral positive allosteric modulator (PAM) of the GABA-A receptor, a neuroactive steroid, will require Drug Enforcement Administration (DEA) scheduling, which will take about three months

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