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FDA committees support esketamine nasal spray for treatment-resistant depression
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In a joint meeting, the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee recommended the approval of esketamine nasal spray CIII for adults with treatment-resistant depression, according to a press release.
The committees voted 14-2, with one abstention, that the data show a favorable benefit-risk profile of esketamine nasal spray (Spravato, Janssen Pharmaceuticals).
In September 2018, Janssen submitted a New Drug Application to the FDA for esketamine.
The committees based their votes on positive data from five phase 3 studies in patients with treatment-resistant depression, which included three short-term studies, a maintenance of effect study and a long-term safety study, according to the release.
Data from the studies demonstrated that treatment with esketamine plus a newly initiated oral antidepressant was linked to rapid reduction of depressive symptoms and delayed time to relapse of symptoms of depression, compared with placebo plus a newly initiated antidepressant. The long-term safety study determined that esketamine was generally tolerable with dosing up to 52 weeks compared with data from short-term studies. Moreover, phase 2 data also supported esketamine for depression.
As for the safety profile, most treatment-emergent adverse events related to esketamine nasal spray occurred shortly after dosing while patients were supervised by a health care professional, were brief and resolved same day, according to the release.
"We are pleased with the advisory committees' vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression," Husseini K. Manji, MD, global head of the neuroscience therapeutic area, Janssen Research & Development, said in the release. "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."
The FDA has already granted Breakthrough Therapy Designations for esketamine for treatment-resistant depression and for MDD with imminent risk for suicide.
The Prescription Drug User Fee Act (PDUFA) date for Spravato is March 4, 2019, according to the release.
Disclosure: Manji is an employee of Janssen.
Perspective
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J. John Mann, MD
This is confirmation by the FDA that ketamine works as an antidepressant and that’s important because the literature – which is mostly IV ketamine and to a much lesser extent intranasal ketamine—indicated that ketamine is different from most antidepressant medications that we’ve ever had in three different ways. First of all, it acts much more rapidly, in hours instead of weeks. Second, when it does work, it seems to work more robustly. Third, it seems to work quite well in patients with treatment-resistant depression. These three characteristics are big advantages.
Another aspect of ketamine that is important is in addition to helping the depression quite a bit in a number of patients, it has a fairly robust effect on reducing suicidal ideation which is important in depressed people and that benefit is not entirely dependent on the antidepressant effect.
Now what we need to do is figure out more clearly how many doses of ketamine should people get and what should the follow-up to ketamine treatment be in terms of medication, psychotherapy and other strategies. Also, what are the long-term safety characteristics of ketamine given in this way and whether we can develop medications that are even better than ketamine that work without producing the sort of “tripping effect” that people can get when they receive ketamine.
This is very good news for depressed patients, but we have more to learn about it.
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