Explaining Medicine
  • News
  • Health & Lifestyle
    • Diet & Weight Management
    • Exercise & Fitness
    • Nutrition, Food & Recipes
    • Prevention & Wellness
  • Conditions
    • Custom1
      • Conditions A-Z
      • Procedures A-Z
      • Allergies
      • Alzheimer’s
      • Arthritis
      • Asthma
      • Blood Pressure
      • Cholesterol
      • Cancer
    • Custom2
      • Chronic Pain
      • Cold Flu
      • Depression
      • Diabetes
      • Digestion
      • Eyesight
      • Health Living
      • Healthy Kids
      • Hearing Ear
    • Custom3
      • Heart
      • HIV/AIDS
      • Infectious Disease
      • Lung Conditions
      • Menopause
      • Men’s Health
      • Mental Health
      • Migraine
      • Neurology
    • Custom4
      • Oral Health
      • Pregnancy
      • Senior Health
      • Sexual Health
      • Skin Problems
      • Sleep
      • Thyroid
      • Travel Health
      • Women’s Health
  • Medications
    • Medications
    • Supplements and Vitamins
  • Medical Dictionary
  • Health Alerts
At new mental health courts in California, judges...
These habits can cut the risk of depression...
Obesity: A Holistic Approach
Just two doctors serve this small Alabama town....
Poison ivy is poised to be one of...
‘Dr. Google’ meets its match in Dr. ChatGPT
Rural nursing home operators say new staff rules...
Fentanyl mixed with cocaine or meth is driving...
Diet Tips for Advanced Prostate Cancer
How to Self-Advocate for Advanced Prostate Cancer
Top Posts

Explaining Medicine

  • News
  • Health & Lifestyle
    • Diet & Weight Management
    • Exercise & Fitness
    • Nutrition, Food & Recipes
    • Prevention & Wellness
  • Conditions
    • Custom1
      • Conditions A-Z
      • Procedures A-Z
      • Allergies
      • Alzheimer’s
      • Arthritis
      • Asthma
      • Blood Pressure
      • Cholesterol
      • Cancer
    • Custom2
      • Chronic Pain
      • Cold Flu
      • Depression
      • Diabetes
      • Digestion
      • Eyesight
      • Health Living
      • Healthy Kids
      • Hearing Ear
    • Custom3
      • Heart
      • HIV/AIDS
      • Infectious Disease
      • Lung Conditions
      • Menopause
      • Men’s Health
      • Mental Health
      • Migraine
      • Neurology
    • Custom4
      • Oral Health
      • Pregnancy
      • Senior Health
      • Sexual Health
      • Skin Problems
      • Sleep
      • Thyroid
      • Travel Health
      • Women’s Health
  • Medications
    • Medications
    • Supplements and Vitamins
  • Medical Dictionary
  • Health Alerts
  • News

    FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression

    by Jon Hamilton March 6, 2019

    Enlarge this image

    Spravato, the brand name for esketamine, a newly approved option for treatment-resistant depression. Janssen Pharmaceutica hide caption

    toggle caption

    Janssen Pharmaceutica

    Spravato, the brand name for esketamine, a newly approved option for treatment-resistant depression.

    Janssen Pharmaceutica

    Editor’s note, March 6, 9:30 a.m.: This story was updated to include information about the price of Spravato.

    The Food and Drug Administration approved the first drug that can relieve depression in hours instead of weeks.

    Esketamine, a chemical cousin of the anesthetic and party drug ketamine, represents the first truly new kind of depression drug since Prozac hit the market in 1988.

    The FDA’s decision came Tuesday, less than a month after a panel of experts advising the agency voted overwhelmingly in favor of approval.

    “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a press release about the decision.

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

    Esketamine works through a mechanism different from those of drugs like Prozac, Charney said. And that is probably why studies show it can often help people with major depressive disorder who haven’t been helped by other drugs.

    “Many of them are suicidal,” Charney said. “So it’s essentially a deadly disease when you haven’t responded to available treatments and you’ve been suffering for years if not decades.”

    Charney was part of the team that first showed two decades ago that ketamine could treat depression. He also is named as co-inventor on patents filed by the Icahn School of Medicine relating to the treatment for treatment-resistant depression, suicidal ideation and other disorders.

    Esketamine, developed by Johnson & Johnson, will be administered as a nasal spray and be used in conjunction with an oral antidepressant. It will be marketed under the brand name Spravato. The FDA has approved it for patients who have failed to respond adequately to at least two other drugs.

    That means about 5 million of the 16 million people in the U.S. with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson.

    From Chaos To Calm: A Life Changed By Ketamine

    Shots – Health News

    From Chaos To Calm: A Life Changed By Ketamine

    But esketamine presents some challenges because of its similarities to ketamine. In high doses, both drugs can cause sedation and out-of-body experiences. And ketamine, often called Special K in its illicit form, has become a popular party drug.

    So Johnson & Johnson is taking steps to make sure esketamine will be used only as intended, Billington said.

    “Spravato will not be dispensed directly to a patient to take at home,” he said. “It will only be available in approved and certified treatment centers.”

    Patients will inhale the drug under supervision at these centers once or twice a week. And they will receive a dose that is unlikely to produce side effects such as hallucinations.

    “The amount of active ingredient that’s in this product, it’s at a very, very low dose,” Billington said.

    Even so, the FDA, according to its press release, is requiring a warning label that says 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,”

    Esketamine’s approval comes as more and more doctors have begun administering a generic version of ketamine for depression. Generic ketamine is approved as an anesthetic, not as an antidepressant. Even so, doctors can legally prescribe it for off-label medical uses.

    And as a growing number of studies have shown ketamine’s effectiveness against depression, ketamine clinics have sprung up around the United States. These clinics often administer the drug in an intravenous infusion that can cost more than $500 per treatment.

    Many doctors who have become comfortable offering ketamine for depression probably won’t switch to esketamine, said Dr. Demitri Papolos, director of research for the Juvenile Bipolar Research Foundation and a clinical associate professor at Albert Einstein College of Medicine.

    For the past 10 years, Papolos has been prescribing an intranasal form of ketamine for children and adolescents who have a disorder that includes symptoms of depression.

    “I’m very pleased that finally the FDA has approved a form of ketamine for treatment-resistant mood disorders,” Papolos said. He said the approval legitimizes the approach he and other doctors have been taking.

    But he hopes that doctors who are currently using ketamine continue to do so. “It’ll be a lot less expensive and a lot easier for their patients [than esketamine],” he said.

    And animal studies show it’s possible that old-fashioned ketamine is a more potent antidepressant than esketamine, Papolos said.

    Esketamine “may not be as effective as a generic that any psychiatrist or physician can prescribe without restrictions,” Papolos said.

    Johnson & Johnson said the wholesale cost of each treatment with esketamine will range from $590 to $885, depending on the dose. That means twice-weekly treatments during the first month will cost centers that offer the drug at least $4,720 to $6,785. Subsequent weekly treatments will cost about half as much.

    The drugmaker says those figures don’t include administration and observation costs.

    Read the article here

    Share this Post

    Share Explaining Medicine Share Explaining Medicine

    FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression was last modified: March 14th, 2019 by Jon Hamilton

    Related

    depressionKetamine
    0 comment
    0
    Facebook Twitter Google + Pinterest
    Jon Hamilton

    previous post
    Alex Trebek diagnosed with pancreatic cancer. A new journey begins.
    next post
    U.S. Cities Skeptical Of FDA Warnings Against Medicine Imports From Canadian Firm

    Related Articles

    9 non-clinical career options for doctors

    March 21, 2019

    Nurse Arrested in Birth to Incapacitated Woman

    January 23, 2019

    Why physicians should beware of 0% financing deals

    April 22, 2018

    For Poorer Americans, Stress Brings Worse Health

    January 8, 2018

    What is Perioral Dermatitis?

    April 17, 2019

    Sexual Assault Has Long-Term Mental, Physical Impact

    October 3, 2018

    Study: FDA Fell Short on Tracking Fentanyl Use

    February 19, 2019

    AI Takes Aim at Lung Cancer Screening

    March 13, 2019

    Report: Most Former Research Chimps Should Move To Retirement Sanctuaries

    May 18, 2018

    Stem Cell Transplant for MS Shows Promise

    March 19, 2018

    Recent Posts

    • At new mental health courts in California, judges will be able to mandate treatment

      September 20, 2023
    • These habits can cut the risk of depression in half, a new study finds

      September 19, 2023
    • Just two doctors serve this small Alabama town. What’s next when they want to retire?

      September 18, 2023
    • Poison ivy is poised to be one of the big winners of a warming world

      September 17, 2023
    • ‘Dr. Google’ meets its match in Dr. ChatGPT

      September 16, 2023

    Keep in touch

    Facebook Twitter Google + RSS

    Recent Posts

    • At new mental health courts in California, judges will be able to mandate treatment

      September 20, 2023
    • These habits can cut the risk of depression in half, a new study finds

      September 19, 2023
    • Just two doctors serve this small Alabama town. What’s next when they want to retire?

      September 18, 2023
    • Poison ivy is poised to be one of the big winners of a warming world

      September 17, 2023
    • ‘Dr. Google’ meets its match in Dr. ChatGPT

      September 16, 2023
    • Terms of Service
    • Privacy Policy

    @2023 - Explaining Medicine. All Right Reserved.


    Back To Top
    Explaining Medicine
    Proudly powered by WordPress Theme: soledad child.