J&J antidepressant eases symptoms, improves sleep in key trial
29 May 2024
Phase 3Clinical ResultPhase 2
Dive Brief:
A new kind of antidepressant eased symptoms and improved sleep among adults enrolled in a large Phase 3 trial, Johnson & Johnson, the drug’s developer, said Wednesday.
J&J is studying the drug, called seltorexant, as an “adjunctive” therapy to background treatment with other antidepressants like SSRIs. The company’s trial enrolled adults with major depressive disorder as well as insomnia, which often accompanies depression and isn’t well treated by SSRIs.
J&J didn’t disclose detailed data in its Wednesday statement. But the company did share the trial met all of its primary and secondary goals, noting the improvement in depressive symptoms among seltorexant-treated participants at study day 43 was both statistically significant and clinically meaningful.
Dive Insight:
J&J was one of the few large pharmaceutical companies to remain active in neuropsychiatry during a pullback in industry investment last decade. Even now, as companies like Bristol Myers Squibb and AbbVie aim to reenter via multibillion-dollar deals, J&J has placed greater emphasis on its brain drugs pipeline.
Seltorexant is one of the company’s chief prospects, with executives predicting last year that it could eventually earn between $1 billion and $5 billion in annual sales.
The drug is aimed at a protein, orexin-2, that’s received attention as possible target for treating narcolepsy. Takeda Pharmaceutical, Jazz Pharmaceuticals and Alkermes are each developing drugs for this purpose that stimulate orexin-2, which is involved in maintaining wakefulness.
In people with depression, however, symptoms can correspond with sleep disturbances that cause insomnia and heighten the risk of a depressive relapse. J&J therefore designed seltorexant as an orexin-2 antagonist, blocking the overstimulation of the receptors that leads to hyperarousal.
Along with improving depressive symptoms, seltorexant treatment also led to better sleep, J&J said. The company’s trial involved people who had previously received SSRI- or SNRI-type antidepressants but didn’t respond well, and who experienced significant sleep disturbances.
Summary study findings will be presented at a medical conference being held this week in Miami, Florida.
J&J said its drug was “safe and well-tolerated” in the study, noting that rates of common side effects were similar in both the seltorexant and placebo groups.
In addition to seltorexant, J&J has also placed significant expectations on another new depression drug known as aticaprant. Results from a Phase 3 study of that medicine could come this year.
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