Now that the Food and Drug Administration is using AI to “speed up” the drug approval process, it seems the sky’s the limit on what wacko products are approved for commercial sale.
The crypto company Tharimmune Inc, for example, was recently given “positive feedback” from the FDA on a drug called Nalmefene, clinically labeled TH104. According to Filter, the drug is being developed as a longer-lasting alternative to Nalaxone, an opioid-reversal agent which typical wears off in 20 to 90 minutes.
Nalaxone is easily administered by non-medical personnel through the nose, and has become widely available either over the counter or through harm reduction programs. Nalmefene is different — and not without controversy. Per Filter, the drug isn’t meant for reversing overdoses in people with substance abuse disorders, but in first responders and military members who might come in contact with them. It also increases the risk of fatal overdose in drug users.
The fact of the matter, though, is that a fentanyl overdose is believed to be nearly impossible through the skin — one would have to ingest, inject, or snort the drug to hope to cause a reaction. However, widely-parroted belief among police officers and law enforcement agencies holds that incidental contact with the substance can cause a first responder to fatally overdose.
The reality is that it’s a crank belief that causes problems when interacting with vulnerable members of the public. As the Maryland Office of Overdose Responce notes, the “notion that one could overdose just from responding to an overdose paints the person overdosing as toxic, untouchable, and unsafe.”
Making the matter more unhinged is the fact that Tharimmune explicitly markets itself as a crypto company, with a clinical pharmacology division attached.
“Tharimmune, Inc. advances institutional blockchain adoption and the digitization of financial markets through a digital assets treasury strategy with Canton Coin,” the company’s website boasts. “Tharimmune also operates a clinical-stage biotech.”
Canton Coin is a digital asset tied to “The Canton Network,” a “privacy-enabled open blockchain network.” In other words, it’s a blockchain meant to link assets from private companies to the blockchain, like Tharimmune’s Nalmefene. How this business model impacts the drug’s development cycle remains to be seen — but if it does get full FDA approval, it’ll be the first of its kind.
