The Food and Drug Administration has announced it will offer 鈥渦ltra-fast review鈥� to two psychedelic drugs: psilocybin and methylone.
The FDA has also authorized initial testing of a drug related to ibogaine, another powerful psychedelic for people with alcohol use disorders. This follows a White House executive order directing the FDA to speed up research on psychedelics, which right now are illegal under federal law.
Here & Now鈥檚 Scott Tong talks to , clinical associate professor of psychiatry at Weill Cornell Medical College and host of the 鈥溾�� podcast, about the latest news surrounding psychedelics.
5 questions with Dr. Gail Saltz
What does expedited reviews of psychedelic drugs by the FDA mean?
鈥淚t means that we can hope for somewhat fast-tracked FDA reviews of these drugs when a drug company or a group that has done clinical trials with one of these medications is ready to do that. So instead of waiting closer to 10 months, it might be more like two months for these particular breakthrough therapies.
鈥淚t also means funding. They鈥檙e going to hallmark $50 million toward increasing research, supplying funding for clinical trials. It may also open up the potential for 鈥榬ight to try,鈥� which means that a patient who is very, very sick and has not responded to anything else may, under approval in specific cases and with supervision, be allowed to try some of these medications. And ultimately, it might push toward rescheduling some of these drugs, which really matters in terms of bringing it to the public, obviously, because as you pointed out, they鈥檙e all illegal now.鈥�
Psilocybin is the active ingredient in magic mushrooms. Talk about what we know about the benefits and the risks.
鈥淭his is the one that is probably closest to FDA approval because it is the closest to being brought to review anyway. First of all, just for all of these meds we are going to talk about, it鈥檚 important to understand they would have to be done under a controlled clinical setting. They鈥檙e really considered a therapy system, not just 鈥榟ere鈥檚 this drug,鈥� but this is done with the therapist.
鈥淚t鈥檚 the closest in early studies; it looks like the response rate may be as high as 50% for people with treatment-resistant depression. This is a group that has failed medication after medication and is very severely depressed, which you should know carries at least a one in 10 mortality rate from death by suicide. These are very ill patients, and close to a 50% response rate is a big deal. There鈥檚 risks of everything from abuse potential, some side effects. If you have a bad experience, that can be rather traumatic, but safety-wise, reasonably safe, under a controlled setting.鈥�
What about methylone and its possibilities for people with post-traumatic stress disorder?
鈥淭his is a mind-altering drug that鈥檚 related to MDMA, which is also part of this package. The issue with MDMA, which people may know as ecstasy, is on the good side, it鈥檚 probably the next closest. It has some phase-three studies.
鈥淚t looks like the response rate can be up to 70%. This is for people with [post-traumatic stress disorder] who have not responded to standard medications and standard psychotherapy, and sometimes they can鈥檛 respond without sort of some changes.
鈥淢DMA has a potential to increase what鈥檚 called neuroplasticity, or the making of new brain circuitry. That flexibility change and that decrease of paranoia from ecstasy can actually make you respond to therapy. It would be used in conjunction with a therapy. It can be very helpful for some people, but it does cause, potentially, again, a bad trip, hallucinations that are disturbing, some nausea, vomiting, that can be uncomfortable.
鈥淢DMA actually was rejected by the FDA when it was brought initially in 2024, which is why they鈥檙e near going with methylone, which actually has fewer side effects in hopes that that would be able to pass.鈥�
Ibogaine is being tested to treat alcohol abuse. Tell me about that.
鈥淚 know this has just gotten a lot of recent attention. From an African shrub, this is a hallucinogen as well. There are reports, and that鈥檚 what鈥檚 important, reports are not well funded, ongoing clinical trials of success in terms of having even just one session and loss of all cravings, and therefore an ability to really treat those abuse disorders.
鈥淥n the other hand, there鈥檚 been the least work on this one; this is definitely the third one that would even come to market. It has some real dangers. Things like heart arrhythmias and seizures, which can lead to death. It has some potentially very serious consequences, in terms of safety; it has to be studied more. There鈥檚 a focus, in terms of the [President] Trump executive order, particularly on veterans who are affected by higher rates of PTSD, treatment-resistant depression and abuse disorders. Part of this executive order is really aimed at trying to address that population who does have a high death-by-suicide rate.鈥�
There are listeners seeking treatment, wondering if psychedelic drugs might be an option for them. How should they start the conversation? How should they set their expectations for all this?
鈥淚 think they have to understand this is not tomorrow but in the next year or two, maybe. But they should also know there are other treatments for treatment-resistant depression or severe PTSD. For example, [transcranial magnetic stimulation], which has a similar rate of success, has to do with an electrical current changing neuroplasticity and can be really helpful for people who failed medications.
鈥淜etamine is in the form of esketamine, which is a nasal spray. Spravato is currently available, is approved, and does have a 60 to 75% response rate with a clinician and therapy. Medication augmentation with other medications like lithium or antipsychotics, switching medications.
鈥淭he most successful, believe it or not, for very, very severely ill people who鈥檝e responded to nothing is electroconvulsive therapy, which I know scares a lot of people. It is really a safe treatment and has a fantastic response rate. So people should understand that they should talk to a psychiatrist who is knowledgeable about their particular issue, about what is currently available for them. People should get treatment. These are serious illnesses. They do have a mortality rate and they really harm quality of life. So there are treatments available that people do respond to.鈥�
____
This article was originally published on
Copyright 2026 WBUR