The primary distinguishing factor in the depression market is a drug’s ability to satisfy unmet needs. Two recent market entrants, Spravato and Zulresso, have appeared highly attractive in their capacity to fulfill needs through their approvals for difficult-to-treat patient populations coupled with their refreshing first-in-class mechanisms. Novelty in mechanism of action is a key differentiator that has finally reached the depression market after decades of stagnated innovation, since long-standing standard-of-care drug classes have been inadequate in treating depression. Traditional therapies may take four to six weeks to produce clinically meaningful effects, and refractory depression persists. 

One of the most recent large-impact events in the depression market was FDA approval of Axsome Therapeutics’ multi-modal drug Auvelity, which is an NMDA receptor antagonist, sigma-1 receptor agonist, and an inhibitor of the reuptake of monoamines. While the approval in August 2022 was just for major depressive disorder (MDD), the drug also has potential to broadly target different lines of therapy, from first-line and antidepressant-unresponsive MDD patients to treatment-resistant depression (TRD) and patients with suicidal ideation, depending on the outcomes of further trial investigations. Thus, Spravato will be a key competitor as it occupies later lines of therapy. However, although Spravato holds the benefit of earlier market entry, Auvelity may secure a broader label and offers the convenience of oral administration compared to Spravato’s intranasal spray administered by a healthcare professional. 

This Datamonitor Healthcare report contains a Disease Analysis module.