One in six adults will have depression at some time in their life, according to the Atlanta-based Centers for Disease Control and Prevention. More than 300 million people of all ages suffer from the mental disorder, and it’s the leading cause of disability worldwide.
While treatments such as antidepressants and psychotherapy
exist, those with severe, treatment-resistant depression often involving
suicidal thoughts may find such options are ineffective.
For
more than a decade, scientists have been pointing to the 1980s “club
drug” ketamine as a possible solution for treatment-resistant
individuals. And on Tuesday, an expert panel recommended the U.S. Food and Drug Administration approve a new nasal spray with ketamine’s active ingredients.
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.
“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.
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.
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.
