Filter Magazine: Now the FDA Wants Nalmefene to Be a Fentanyl-Exposure “Prophylactic”
Source: Filter Magazine
Publication Date: November 14, 2025
Keywords/Topics: Nalmefene, Opioid, Naloxone
Now the FDA Wants Nalmefene to Be a Fentanyl-Exposure “Prophylactic”
"The Food and Drug Administration is reportedly providing guidance and “positive feedback” for a proposed nalmefene product that will last 24 hours, designed for military and first responders to self-administer as a precaution against secondhand fentanyl exposure. TH104 is being developed by Tharimmune, a blockchain-focused digital finance company with a biotech research arm that consists of basically just this product. The company announced November 13 that the FDA will allow the new drug application (NDA) submission without any clinical trials, since it had already completed a TH104 trial as a treatment for chronic itchiness caused by an autoimmune condition.
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On November 11, two days before Tharimmune’s announcement, the American College of Medical Toxicology (ACMT) and American Academy of Clinical Toxicology (AACT) published a position statement focused on passive opioid exposure among first responders. It warns that nalmefene has “limited data regarding its use in fentanyl overdose” and “should not be considered the first-line agent for opioid reversal until more robust data are available.” In 2023 the ACMT and AACT published a position statement focused on nalmefene specifically, describing why it should not be used in place of naloxone."