Together, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted the benefits of Janssen Pharmaceutical Companies' fast-acting esketamine 28-mg single-use nasal spray outweigh the risks.
"The committees based their support on the safety and efficacy data from five Phase 3 studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study, according to a Janssen Pharmaceutical Companies press release. And any adverse effects (increased blood pressure, dizziness, dissociative symptoms) "occurred shortly after dosing...were transient...and resolved the same day."
The company also proposed a Risk Evaluation and Mitigation Strategy (REMS) to further assess the drug’s effectiveness.
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"The thing I'm most concerned about really is diversion and misuse and things like that," temporary FDA voting member Lee Hoffer of Case Western Reserve University told Medscape. Hoffer has urged the agency to keep a close eye on safety.
Esketamine’s fast-acting role spurred by ketamine’s active ingredients is what makes this possible treatment for severe depression most useful, experts say. Unlike other commonly used treatments, which can take several weeks to begin working, esketamine can offer symptom relief more quickly, potentially lowering one’s risk of self-injury or suicide.
But ketamine in general has yet to be federally approved, largely because there’s still a lot scientists don’t know.
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According to Medscape, it's still unclear what about ketamine's biology triggers an antidepressant response in one day when most antidepressants usually need two weeks or longer to make an impact. And what does ketamine do to the brain that antidepressants don't do?
Still, "well over 3,000" patients in the U.S. and Canada have been treated with ketamine so far, Yale University psychiatry professor Gerard Sanacora told NPR in 2017.
When other doctors ask him how he can offer the drug to patients with limited information about its effects, Sanacora responds with this answer: "If you have patients that are likely to seriously injure themselves or kill themselves within a short period of time, and they've tried the standard treatments, how do you not offer this treatment?"
When depressed patients who have exhausted their options take ketamine, Sanacora said, 50-75 percent of them feel at least 50 percent better within one day.
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According to the New York Times, despite federal approval, clinics all over the country have began administering intravenous ketamine for depression "as a series of treatments, over a period of days or weeks, and sometimes including follow-up or 'booster' visits months later." Such "off-label" treatments average $3,000 and usually aren't covered by insurance, nor have their effectiveness been thoroughly studied.
But if approved, ketamine’s “chemical sibling” esketamine, which would be covered by most insurers, may pave the way for the first new depression treatment in 30 years. The FDA has until March 4 to decide.
More about the FDA expert panel meeting at fda.gov.