The just-approved treatment is considered a major advance, but
there's a big caveat if you're over 65
by Hallie Levine, AARP,
March 8, 2019
Up to one-third of
adults with major depression battle symptoms such as persistent feelings of
sadness, trouble sleeping, fatigue and suicidal thoughts that don’t respond to
treatment. Yet there’s been very little new on the market since Prozac
revolutionized the treatment of depression in 1988. Until now. This past
Tuesday, the Food and Drug Administration approved the nasal spray esketamine
as the first new type of treatment for depression in over three decades.
“It’s quite possibly
the biggest advance for mental health in the past 50 years,” says Gerard
Sanacora, M.D., director of the Yale Depression Research Program in New Haven,
Conn. “It truly offers hope to people who have not responded to classical standard
antidepressant treatments.”
There are three main
reasons, he says: First, it seems to be effective in cases where other standard
antidepressants like sertraline (Zoloft), bupropion (Wellbutrin) and duloxetine
(Cymbalta) have failed. Second, it acts very rapidly. “We used to tell our
patients it could take weeks or even a few months before they would begin
feeling better, and now this offers potential benefits within hours or days,”
he explains. Finally, it’s a completely new way of treating depression. “Almost
all of the other antidepressants on the market target two main neurotransmitters:
serotonin and norepinephrine,” Sanacora says. These two neurotransmitters, in
turn, activate another neurotransmitter, glutamate, which is what boosts your
mood. Esketamine instead works directly on glutamate, which is why its effect
is almost immediate.
On the downside, the
data on the effectiveness of esketamine for those over 65 is less encouraging.
(More on that below.) And there are still some concerns related to the fact
that it is closely related to ketamine, a drug typically used in anesthesia
that rode to fame in the 1980s and 1990s as the party drug “Special K.” “There
are definitely concerns about addiction and abuse,” says Amit Anand, a
psychiatrist at the Cleveland Clinic who has been studying the use of ketamine
for depression for 20 years. Because of this, esketamine will only be offered
in doctor’s offices or medical clinics, under close supervision.
Here’s what you need to know:
Esketamine is not as
effective in those over 65. Company
data submitted to the FDA for approval, based on more than 1,700 adults with
treatment-resistant depression, found that more than two-thirds of those who
took esketamine (brand name Spravato) along with a new oral antidepressant
experienced significant relief of symptoms within four weeks, compared with
only about half of those who took a placebo. They were also less likely to
relapse over the long term.
But the data among
people over 65 is less strong. While the older adults did report improvement,
it wasn’t statistically significant. “It appeared that people who had an onset
of depression later in life may not have responded as well,” says Sanacora, who
was one of the study’s investigators. “One thought is that later-in-life
depression is different from depression that begins earlier, because it has a
different neurobiology. It’s due to vascular changes.” But since it can affect
cognition and perception, it may not be the best drug for older adults anyway.
“You really need to weigh the potential risk-benefit ratio a little
differently than when you treat a younger person,” Sanacora says.
It’s not a first-line
drug. “People are
flooding our offices with calls saying that they want this, but it’s not the
treatment for just anybody. It’s for people who have not responded to standard
antidepressants,” Sanacora explains. You need to have tried at least two
antidepressants during your current episode of depression, without success. And
even when you do take this nasal spray, you have to take a standard antidepressant
with it, as well as engage in other treatments such as talk therapy, he adds.
There are some pretty
serious side effects. Spravato will
come with a black box warning, the strictest safety warning put in the labeling
of prescription drugs by the FDA. The most common side effects include
disassociation (having trouble thinking), dizziness, nausea, vertigo, anxiety,
feeling tired, increased blood pressure, vomiting and feeling drunk. You have
to stay in your provider’s office for at least two hours after getting the
dose, and you can’t drive for 24 hours. “There are definitely changes in
cognition and perception, and people who experience it say it is pretty weird —
and in some cases, even a little frightening,” Sanacora says.
Cost is definitely a
concern. Unlike, say,
generic Prozac, which you can often find online for as little as $1.50 for a
one-month supply, the first month of therapy on Spravato is expected to cost
between $4,720 and $6,785 before insurance, rebates and discounts. (After the first
month, the price drops to between $2,360 and $3,450.) “That comes to about $500
to $800 per dose, making it more on par with other interventional treatments
such as electroconvulsive therapy [ECT] or transcranial magnetic stimulation
[TMS],” Sanacora says. But if you’re strapped for cash, there may be a loophole
for your doctor to consider, Anand says. As he notes, your doctor could
conceivably administer an IV dose of ketamine, which has the same effects but
is considerably cheaper.
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