Generic name: esketamine
Company: Johnson & Johnson
Disease: major depressive disorder
2024 sales estimate: $1.30 billion
Spravato, a tweaked form of the “party drug” ketamine, has been hailed as the first promising new treatment for major depression to win approval in years, and it carries high financial expectations from developer Johnson & Johnson.
Delivered as a nasal spray, Spravato is approved alongside oral antidepressant treatment. It's limited to adults who have tried but failed at least two different antidepressants. Because of its safety risks—and the potential for abuse and misuse—the FDA required a restricted distribution system. Patients can only take it at certified treatment centers rather than at home.
The spray is sticker-priced at $6,785 for the higher dose for the first month of therapy; after that, the list price drops to $3,450 maximum.
Despite Spravato's administration restrictions, a couple of phase 3 trial misses and its relatively high cost, J&J has high hopes for the drug. On the company’s fourth-quarter earnings call in January, CEO Alex Gorsky named it and FGFR-targeted cancer therapy Balversa as two promising new drugs headed for blockbuster sales.
How? First, about one-third of U.S. adults with severe depression are treatment-resistant and therefore might be eligible for Spravato, J&J figures. And the drug’s efficacy was evident in a short-term, four-week clinical trial and a long-term study, despite its disappointing numbers in two other pivotal tests.
In one short-term phase 3 in patients under 65, Spravato, given on top of an oral antidepressant, significantly improved depression symptoms versus the antidepressant pill alone. That's the first time any drug has done so in a clinical trial, J&J said when it unveiled the results last May.
As for the longer-term maintenance trial, patients whose symptoms abated on Spravato continued the combination regimen, and they were found to be 51% less likely to relapse versus those in the control arm.
But Spravato has fallen short in some studies. Two of the three pivotal trials J&J ran to assess its short-term effects missed their primary endpoints. For instance, in a phase 3 in patients aged 65 and above, the drug showed “clinically meaningful effects,” J&J said, but failed to meet the statistical significance standard to demonstrate effectiveness.
Still, an FDA advisory panel backed the drug in a 14-2 vote, partly because of the significant need for new options for treatment-resistant patients.
Jefferies analysts had previously predicted Spravato could reach $3 billion in peak sales. Evaluate Pharma, for its part, projected $1.30 billion in sales by 2024.