Johnson & Johnson is continuing to build out its neuroscience pipeline with positive topline data for its experimental depression and insomnia drug in a late-stage trial.
The drug, seltorexant, is an antagonist of the human orexin-2 receptor. It hit both primary and secondary endpoints in a Phase 3 trial in patients with major depressive disorder and insomnia based on the Montgomery-Asberg Depression Rating Scale. The antagonist showed “statistically significant and clinically meaningful” improvements in depression symptoms after 43 days when used as an adjunctive treatment with other antidepressants.
Patients on the drug who didn’t have an adequate response to other antidepressants also saw “improved” sleep in the MDD2001 study. According to J&J, there are no approved treatments for patients with both major depressive disorder and insomnia.
“Seltorexant has the potential to fill a significant unmet need for new therapies to treat patients experiencing depression and insomnia, and most importantly, to improve outcomes and quality of life for these patients,” Andrew Krystal, professor of psychiatry at UCSF’s Weill Institute for Neurosciences, said in a statement.
Bill MartinOver the last several years, J&J has been working on its neuro pipeline. In 2021, Bill Martin, now the global neuroscience therapeutic area head for J&J’s innovative medicine business, said neuroscience was entering “a golden age.” And then in December, the company said seltorexant is one of several drugs that could generate between $1 billion and $5 billion in sales.
J&J currently has 10 different assets in its neuro development pipeline for various indications, including Alzheimer’s disease, bipolar depression and epilepsy, among others.
It’s also working on expanding indications for its anti-depression intranasal Spravato, a form of ketamine.
On Wednesday, the company revealed Phase 4 data for the spray, this time as a monotherapy. It said the drug hit both primary and secondary endpoints showing that patients had statistically significant and clinically meaningful improvements in depression symptoms within 24 hours after the first dose. Patients sustained those improvements through four weeks of treatment.
Spravato is already approved in combination with an oral antidepressant for treatment-resistant depression and depressive symptoms in adults with major depressive disorder and suicidal thoughts or behaviors. Earlier this week, Stifel analysts told investors they expect Spravato to generate more than $1 billion in sales this year “despite less than stellar efficacy and similar challenges,” like its side effects and challenges accessing the drug.
Both readouts are expected to be presented this week at the American Society of Clinical Psychopharmacology’s annual meeting.