Esketamine: A New Hope for Treatment-Resistant Depression (FDA Advisory Committees, 2019)

Introduction:
The FDA reviewed a new treatment called esketamine, a nasal spray developed for people with treatment-resistant depression (TRD). TRD is a serious condition where traditional antidepressants fail to work. This medication offers new possibilities for those who haven’t found relief with other options.

Key Points for Patients:

  1. What is Esketamine?
    • Esketamine is a nasal spray designed for adults whose depression hasn’t improved after trying multiple medications.
    • It is fast-acting, with effects often felt within hours to days.
  2. FDA Advisory Meeting (2019):
    • Experts analyzed whether esketamine is effective and safe.
    • The committee focused on potential risks, such as side effects like dizziness or dissociation, and how these compare to its benefits.
    • The review highlighted esketamine’s ability to rapidly reduce symptoms of depression, especially in urgent cases.
  3. How It Works:
    • Esketamine targets a different brain system than traditional antidepressants, offering hope for people whose depression hasn’t improved with common treatments.
  4. Safety Measures:
    • The FDA recommended controlled use, requiring patients to take the medication in a clinical setting under supervision.

The VitalPoint for Patients:
Esketamine provides a new option for people who feel like they’ve tried everything for their depression. If you or someone you know is struggling with treatment-resistant depression, talk to a doctor about whether this medication might be an option.

Learn More:

  • FDA Esketamine Information
  • FDA Drug Approval Process
    FDA (2019b). Psychopharmacologic drugs advisory committee (PDAC) and drug safety and risk management (DSaRM) advisory committee meeting; agenda topic: The committees will discuss the efficacy, safety, and risk-benefit profile of new drug application (NDA) 211243, esketamine 28 mg single-use nasal spray device, submitted by Janssen pharmaceuticals, inc., for the treatment of treatment-resistant depression. https://www.fda.gov/media/121376/download.
VitalPoint Technologies, Inc.

Disclaimer

None of the statements in this announcement or via any web sites linked herein have been evaluated by the FDA. Furthermore, none of the statements in this announcement or any web sites linked herein should be construed as dispensing medical advice or making claims regarding the cure of diseases. You should consult a licensed health care professional before starting any supplement, dietary, or exercise program, especially if you are pregnant or have any pre-existing injuries or medical conditions. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any diseases.

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