NIH-funded research R01 grant

Dexmedetomidine Sublingual Film for Autonomic Crises in Familial Dysautonomia

Official title: Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients with Familial Dysautonomia

Funded at New York University School of Medicine · NIH-11177687 · Data updated 2026-11-12

This project looks at using a sublingual film medication to help people with familial dysautonomia manage sudden, severe changes in blood pressure and heart rate at home.

More Dexmedetomidine research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionNew York University School of Medicine
NIH-funded
Lab location1 site (New York, United States)
Project startSeptember 15, 2023
Project endAugust 31, 2028
Funding year2025
Award (this year)$377,195
NIH project number5R01FD007826-03
Project IDNIH-11177687 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are patients diagnosed with familial dysautonomia who experience frequent hyperadrenergic autonomic crises.

Less likely to help

Patients without familial dysautonomia or those who do not experience hyperadrenergic autonomic crises would not directly benefit from this specific treatment approach.

What this research studies

Familial dysautonomia (FD) is a rare genetic condition that causes many health challenges, including frequent and severe episodes called hyperadrenergic autonomic crises. These crises involve a sudden spike in blood pressure and heart rate, often with vomiting, and can be dangerous. Current home treatments can have serious side effects like sedation or respiratory problems. This project aims to find a safer and more effective way to manage these crises at home by exploring a sublingual film containing dexmedetomidine, a medication that could help calm the body's overactive stress response during these episodes.

Why it matters

Potential benefit: If successful, this new treatment could provide a safer and more effective way for patients with familial dysautonomia to manage severe autonomic crises at home, potentially preventing serious complications.

How similar studies have gone: This project proposes a novel approach to treating these crises, indicating that current methods are insufficient and this specific drug delivery for this condition is largely untested.

Where this research is happening

  • New York University School of Medicine
    New York, United States
    Active

Researchers

  • Principal investigator: Gonzalez-Duarte Briseno, Maria Alejandra — New York University School of Medicine
  • Study coordinator: Gonzalez-Duarte Briseno, Maria Alejandra

Related research

Other NIH-funded projects on the same topics.

  • Naloxone-DEXmedetomidine combo to calm methamphetamine agitation in polysubstance use

    A study at Marshall University tests whether a naloxone and dexmedetomidine combination can safely and effectively reduce agitation in people acutely intoxicated with methamphetamine and other substances.

    NIH research Marshall University · Huntington, UNITED STATES · NIH-11420634

  • Dexmedetomidine Sublingual Film for Flare-Ups in Familial Dysautonomia

    A new dexmedetomidine pill under the tongue is being tested to help people with familial dysautonomia manage sudden sympathetic flare-ups at home.

    NIH research New York University School of Medicine · New York, United States · NIH-11361421

  • Preventing Confusion After Heart Surgery with a Special Sleep Medication

    This project looks at whether a medication called dexmedetomidine can help prevent confusion and memory problems in older patients after heart surgery.

    NIH research Massachusetts General Hospital · Boston, United States · NIH-11116932

  • New treatment for severe autonomic crises in patients with familial dysautonomia

    This study is looking at a new way to help people with familial dysautonomia manage sudden, severe symptoms using a special film that dissolves under the tongue, which could make it easier and safer for them to handle these episodes at home.

    NIH research New York University School of Medicine · New York, United States · NIH-10932210

  • Using low doses of dexmedetomidine to treat respiratory failure from fentanyl overdose

    This study is looking at how a small amount of a brain medication called dexmedetomidine can help people breathe normally again after they've had trouble breathing from a fentanyl overdose.

    NIH research Cleveland Clinic Lerner Com-Cwru · Cleveland, United States · NIH-10701905

  • Using a new medication to help treat opioid withdrawal symptoms

    This study is looking at a new film you place under your tongue that contains a medication called dexmedetomidine to help ease withdrawal symptoms for people dealing with opioid use disorder, especially those using strong opioids like fentanyl, and it aims to find out if this treatment is safe and works better than cur

    NIH research New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC · New York, United States · NIH-10478324

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.