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FDA Approves Esketamine Nasal Spray For Treatment-Resistant Depression

by D
6 years ago
in Science & Technology
Reading Time: 4 mins read
A A
Janssen Pharmaceutics

Janssen Pharmaceutics

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Anyone’s who ever lived with depression has, at some point, probably hoped against hope that they could just snap their fingers and find some relief.

We’re not quite there yet, but a newly-approved treatment for depression has the potential to provide relief in a matter of hours.

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Antidepressants can be tricky.

Image credit: Unsplash | Dmitry Bayer
Unsplash | Dmitry Bayer

Patients generally have to take them for some time before they start to see benefits. Sometimes, even after a few weeks, an antidepressant may not have had enough time to show its effects.

The new drug is different.

Image credit: Max Pixel
Max Pixel

Released by Janssen Pharmaceuticals, it goes by the trademark name ” Spravato “. It isn’t a pill, either — it’s actually a nasal spray that comes in pretty much the same format as the stuff you can use for a stuffy nose.

It was just approved by the FDA.

Image credit: Wikimedia Commons | The U.S. Food and Drug Administration
Wikimedia Commons | The U.S. Food and Drug Administration

In their release , Dr. Tiffany Farchione, acting director of the agency’s Division of Psychiatry Products noted, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.”

It’s made of esketamine.

Image credit: Wikipedia | Ben Mills
Wikipedia | Ben Mills

If that name rings a bell, it’s probably because of the chemical’s cousin, ketamine. While the two chemicals are slightly different, they come from the same family — and their family history is fascinating.

Ketamine was originally intended as an anesthetic.

But over the years, it gained popularity as a party drug. The euphoric state it could induce allong with visual hallucinations made it one of the more popular recreational drugs of 90’s rave culture.

Esketamine has shown big benefits.

Image credit: Unsplash | Yuris Alhumaydy
Unsplash | Yuris Alhumaydy

Known as a fast-acting antidepressant, esketamine works differently from more traditional treatments like Prozac. In short, it provides a new potential pathway for treatment in patients with treatment-resistant depression.

It’s not the first-line option.

Image credit: Unsplash | rawpixel
Unsplash | rawpixel

The FDA says that once it becomes available for doctors to prescribe, it will only be an option for patients who haven’t responded well to two or more other drugs.

How’s it taken?

Image credit: Wikimedia Commons
Wikimedia Commons

The nasal spray component is a good delivery system for fast-acting therapy. But a pill needs to be taken alongside the spray. Still, it can show results in as little as a few hours.

The rollout will be a bit slow.

Image credit: Flickr | liliannorman
Flickr | liliannorman

For the first little while, it won’t be at traditional pick-up-and-take-home prescription. It will only be used at clinics under the supervision of doctors, in order to prevent misuse.

Why the supervision?

Image credit: https://commons.wikimedia.org/wiki/File:(S)-(%2B)-ketamine.png
https://commons.wikimedia.org/wiki/File:(S)-(%2B)-ketamine.png

At high doses, drugs in this family can be harmful or even deadly . While both esketamine and ketamine are clinically useful, the potential for abusing them is pretty high.

It’s the first breakthrough in this field in a long time.

Image credit: Wikipedia | Lanfear's Bane
Wikipedia | Lanfear’s Bane

The last big new treatment for depression to get FDA approval was fluoxetine, better known under the trademark name Prozac. That was all the way back in 1987 , so it’s been awhile.

Is it controversial?

Image credit: Unsplash | Zoltan Tasi
Unsplash | Zoltan Tasi

It doesn’t look like it. The medical community has been mostly receptive to the development of these drugs as treatment for people who haven’t responded to more traditional treatments.

It’ll come with a warning label.

An FDA-mandated label on the medication will say patients “are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.”

It’ll be on the market soon.

Image credit: Wikimedia Commons | he U.S. Food and Drug Administration
Wikimedia Commons | he U.S. Food and Drug Administration

While it’ll be kept under fairly tight control, it’s exciting news for the millions of Americans who live with major depression as it represents an alternative to medications that don’t work well with some patients.

Tell us what you think.

Image credit: Janssen Pharmaceutics
Janssen Pharmaceutics

Remember, you don’t have to go it alone. If you’re depressed or having dark thoughts, talk to someone — a friend, a family member, or a doctor. You can call the National Suicide Prevention Lifeline 24/7 at 1-800-273-8255.

Tags: Science

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