Sage Therapeutics and Biogen have recently announced positive results from a pivotal Phase III trial for their novel, GABA A receptor allosteric modulator, antidepressant zuranolone. Zuranolone could alter the way major depressive disorder (MDD) is treated with a focus on episodic treatment instead of maintenance treatment, says GlobalData, a leading data and analytics company.

Philippa Salter, Neurology Analyst at GlobalData, comments: “Following the discovery of monoaminergic antidepressants, a large number of antidepressants with a similar mechanism of action were developed. This means that the MDD market is now highly competitive, and therefore, companies are developing novel products to give them a competitive edge in the market.”

There is a significant unmet need within the MDD market for pharmacotherapies that can demonstrate rapid and sustained antidepressant effects. Most currently available products show antidepressant effects only after several weeks of treatment and require long-term, continuous administration.

Salter continues: “Zuranolone, as an acute rapid response therapy (RRT), could dramatically alter the way that MDD is treated. It has demonstrated significant antidepressive effects within days of initiation, and its course of treatment is only 14 days long, which would be viewed particularly advantageous by patients.”

Although zuranolone could alter the way MDD is treated, as a short course treatment, sales for zuranolone could be limited when compared with maintenance therapies for MDD. As such, GlobalData forecasts that zuranolone will generate global sales of approximately $137m by 2029.

There are several other late-stage products, including Axsome Therapeutics’ AXS-05 (bupropion + dextromethorphan), and Relmada Therapeutics’ REL-1017, which have also demonstrated rapid and sustained antidepressant effects in clinical trials that will provide significant competition for zuranolone.

Salter adds: “AXS-05 is expected to launch later this year, a couple of years before zuranolone and REL-1017, giving it first-to-market advantage. In addition, AXS-05 is being developed as both a monotherapy and an adjunctive therapy for MDD. This could enable it to reach a wider patient population compared with zuranolone, which will be co-initiated with a new standard antidepressant. GlobalData anticipates that AXS-05 will have the potential to become a blockbuster drug, and could generate global sales of approximately $1.3bn by 2029.”