Author Interviews, Pain Research / 11.09.2025
FDA Approves Tonmya: First-in-Class, Non-Opioid Analgesic for Fibromyalgia
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Dr. Jain[/caption]
MedicalResearch.com Interview with:
Rakesh Jain, MD, MPH
Clinical Professor at the Department of Psychiatry
Texas Tech University School of Medicine- Permian Basin
Midland, Texas
MedicalResearch.com: Would you briefly explain the condition of fibromyalgia? Whom does it primarily affect and what are the symptoms?
Response: Fibromyalgia is the prototypical example of a type of pain called nociplastic pain, or pain that comes from altered pain processing in the central nervous system. It is mainly characterized by widespread pain, non-restorative sleep, fatigue and cognitive impairment (brain fog). Over 10 million adults in the United States are affected by this disease, most of whom are women.
Dr. Jain[/caption]
MedicalResearch.com Interview with:
Rakesh Jain, MD, MPH
Clinical Professor at the Department of Psychiatry
Texas Tech University School of Medicine- Permian Basin
Midland, Texas
MedicalResearch.com: Would you briefly explain the condition of fibromyalgia? Whom does it primarily affect and what are the symptoms?
Response: Fibromyalgia is the prototypical example of a type of pain called nociplastic pain, or pain that comes from altered pain processing in the central nervous system. It is mainly characterized by widespread pain, non-restorative sleep, fatigue and cognitive impairment (brain fog). Over 10 million adults in the United States are affected by this disease, most of whom are women.
Dr. Casale[/caption]
Thomas B. Casale, M.D.
Professor of Medicine and Pediatrics
Chief of Clinical and Translational Research
Division of Allergy and Immunology
USF Health Morsani College of Medicine
University of South Florida
Tampa, Florida
MedicalResearch.com: What is the background for this study?
Response: The data leading to FDA approval of neffy came from extensive pharmacokinetic and pharmacodynamic studies. As with previous epinephrine delivery devices, the FDA asked for data showing that after delivery of neffy the epinephrine blood levels and expected changes in pulse and blood pressure were similar to those achieved with injectable formulations of epinephrine. neffy performed as expected with blood levels of epinephrine bracketed by those achieved with EpiPen and a needle and syringe along with increases in pulse and blood pressure compatible with the epinephrine levels measured.
Additionally, clinicians are interested in whether neffy would perform similarly in real clinical situations. The data from the neffy experience program provides real-world assurance that neffy can effectively treat acute allergic reactions. Given the large number of patients and the similar findings to those achieved with injectable epinephrine in previous studies, the data should provide assurance that neffy can be an effective substitute for injectable epinephrine in patients that desire a needle-free option.