FDA Approves New Nasal Spray for Treatment-Resistant Depression

By bp Magazine
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The FDA’s approval of Spravato (esketamine) offers hope to millions living with hard-to-treat depression.



March 5, 2019—The FDA has approved Johnson & Johnson’s Spravato for treatment-resistant depression. The drug represents the first new major pharmaceutical advancement in the treatment of depression since Prozac was introduced in the late 1980s.

“This is potentially a game changer for millions of people,” said Dr. Dennis Charney, M.D., dean of the Icahn School of Medicine at Mount Sinai in New York. “It offers a lot of hope.”

According to the World Health Organization, depression is leading cause of disability worldwide, and it affects over 16 million Americans each year. Many of them suffer from treatment-resistant depression, which increases the risk of suicidal ideation, hospitalization and self-harm, notes the FDA.

“[Spravato] has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC.

While Prozac and other similar medications work by targeting the neurotransmitter serotonin, Spravato (chemical name esketamine) targets glutamate, levels of which are depleted in people with major depressive disorder. This new drug is chemically related to ketamine, the 90s “party drug” known by the street name Special K.

While esketamine is chemically similar to ketamine, it is not the same. Rather, the two are essentially “chemical cousins.” While these molecules are similar to one another, the new drug is actually more potent, and it has less unpleasant dissociative effects. It is also easier to administer. Spravato will be available as a nasal spray, whereas traditional ketamine is given intravenously and at a higher dose.

Spravato is currently approved for treatment-resistant depression, and phase III clinical trials are being conducted regarding its effictiveness on those with major depressive disorder who are at high risk of becoming suicidal. In the coming years, Janssen (a subsidiary of Johnson & Johnson) may also investigate Spravato’s efficacy in regard to other mental health conditions, such as bipolar and schizophrenia, but the company has made no formal announcement at this time.

Quick facts on Spravato:

  • a new option for treatment-resistant depression is available as a nasal spray
  • used in conjunction with an oral antidepressant
  • only for people who have tried at least two other antidepressants
  • administered only in a certified doctor’s office or clinic
  • taken once or twice a week for the first month, then weekly
  • requires monitoring for at least two hours after taking the drug
  • use prohibits driving and operating heavy machinery for the rest of the day
  • costs between $590 and $885, before insurance and rebates
  • tool on www.spravato.com will assist patients looking for nearby clinics

9 Comments
  1. I cant believe that this site is available all the others I came across were from years ago. However I am 61 and in good health besides MDD and severe anxiety. My depression spawns back for over 3 decades 18 different anti-depressants 25+ years of self medicating with alcohol and sometimes illegal drugs the found the opiates after neck surgery and 4 wisdom teeth pulled. The opiates made me feel normal like everyone else for the first time I can remember, that took a turn when I ran out of sources to keep myself form withdrawals so I went the Suboxone route for 4+ years and just went thru 36 treatments of deep Neurostar TMS therapy after saying all this I am still on Seroquel 200mg- Zoloft 200mg- Lamictal- Suboxone and still no relief. When I first read about this new treatment I got excited because my next step would be ETC and I am willing at this time in my life to try anything. I believe its better to have a small amount of hope than no hope at all. I have great insurance and the price of my 3 antidepressants would cost about $1500.00 each month. I understand why the cost is so high on a drug that seems to be possible cure so why would my insurance not be up to trying to get me off these other drugs with a estimated yearly cost $1800k.

  2. I’m a 71 year old woman with severe depression for 20 years or more I. use a med I think Prozac not sure I’ve tried different ones Zoloft that’s the one I use now I take 2 100mg at bedtime- I Have A- Fib and am on Blood thinner Eliquis 5mg tablets twice a day- This new drug scares me because I read it could cause LSD effects and was like special K- I’ve never done drugs that scares me , what will be the long term side effects like all this other medicine that we thought was safe and now there are law suites everywhere and people dying. I live in Comanche; Ok

  3. I looked into ketamine as an option. Only one place in a reasonable driving distance from me offered ketamine and TMS and they didn’t accept medicare plans or Medicaid so they weren’t options for me. I had to stay with ECT. I have to wonder if it wippvbe the same for this drug. If it was an option for me I would try it if I could afford it.

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