FDA Says Psychedelic Drug Applications Now “Fully a Third” of Workload
Federal officials are signaling growing momentum behind psychedelic drug development. At a recent American Brain Coalition webinar, FDA Division of Psychiatry Director Tiffany Farchione revealed that psychedelic programs now consume a third of her workload. NIDA Director Nora Volkow went further, calling these substances “truly game changers.”
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| Key Takeaways |
|---|
| Psychedelic applications now represent one third of FDA psychiatry division reviews |
| Several programs are close to submitting marketing applications |
| NIDA Director questions Schedule I placement for classical psychedelics |
| Single doses may create lasting brain changes without chronic dosing |
| Scheduling could shift after FDA approval |
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Industry Interest Surges
The flood of applications reflects broad enthusiasm. “It’s not just an interest from the public,” Farchione said. “It’s an interest from academia, from commercial drug sponsors as well.”
She acknowledged challenges ahead. Blinding remains particularly difficult. “Let’s face it, it’s nearly impossible to blind these studies,” she noted. The agency has offered guidance, though. Sponsors can run studies with multiple doses to establish dose response relationships.
Despite the MDMA setback, Farchione expressed optimism. Several programs are nearing the finish line with their marketing applications.
A Pharmacological Revolution
Volkow described psychedelics as revolutionary from multiple angles. Traditional psychiatric medications require daily dosing to maintain effects. Psychedelics appear to work differently.
A single administration of psilocybin or LSD “can actually strengthen synapses and actually create new synapses in the brain,” Volkow explained. This mechanism challenges conventional drug development thinking.
The Scheduling Question
Both officials addressed the regulatory burden of Schedule I status. Volkow agreed with panelist David Nutt that current scheduling makes research unnecessarily expensive.
“There’s no evidence, certainly for the classical psychedelics, that they produce addiction,” Volkow said. “So I don’t understand” their current placement.
Farchione offered a path forward. FDA approval would automatically trigger rescheduling discussions. “If we ultimately do approve something and endorse it and say it has a therapeutic use, then it will no longer be Schedule I,” she confirmed.
The DEA would then determine the new classification.
