Welcome to the Empowered Patient Podcast with Karen Jagoda. This show is a window into the latest innovations in applying generative AI, novel therapeutics and vaccines, and the changing dynamics in the medical and healthcare environment. One focus is on how providers, pharmaceutical companies, and payers are empowering patients. In addition, conversations are often about how providers, care facilities, pharmaceutical companies, and payers are being empowered by technology to improve patient outcomes and reduce friction across the healthcare landscape.
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Mar 19, 2025
Joe Tucker, CEO of Enveric Biosciences, is developing non-hallucinogenic psychedelic drugs that aim to induce neuroplasticity and beneficial changes in the brains of patients with mental health disorders. The FDA rejected the approval of MDMA for PTSD treatment due to concerns about the inability to run blind trials to separate the placebo effect from the effects of the drug. Enveric addresses the promise of neuroplastic drugs that stimulate the neural connectivity between the prefrontal cortex and amygdala without hallucinations.
Joe explains, "And the problem, endemic to hallucinogenic psychedelics, is that there's no question in the patient's mind, in the doctor's mind, in everybody's mind whether or not they got an hallucinogenic agent. And so when everybody knows whether they got it or not, that's what you call functional unblinding. And so the FDA was very concerned about this. They said you must be able to separate the placebo from the actual drug. Until we see data that gives us confidence that you separated it, we can't approve it, even though it looks like a very positive impact for the patients."
"We were looking precisely to see if we could remove the hallucination without removing the benefit. So that's the field we're in. What's it being called right now? It's a very, very new field being called the non-hallucinogenic neuroplastogen- neuroplastogen indicating that it induces neuroplasticity, in other words, rewiring of the brain, but does so without inducing hallucination. We saw two challenges coming: How do you separate placebo from non-placebo effect and the treatment?"
"Then the idea would be, hopefully, this psychedelic treatment was so impactful, you didn't need to take any other treatment again for a long period of time. And that seems pretty aspirational, honestly, and likely to get in the way of real patient acceptance that you want something which is not so sort of rock your world. Most people don't want that. They like to be able to have a drug that is like, take an aspirin. You take it every day. You don't have a big impact. You can go about your life. You don't really notice it other than you feel better. And that's the idea behind the non-hallucinogenic neuroplastogen. It fits much more in line with what patients are looking for and expecting and doctors, the whole healthcare system. It just makes a lot more sense."
#MentalHealth #MentalHealthDisorders #MentalHealthEpidemic #Depression #Anxiety #PTSD #Neuroplastogens #Psychedelics
