Robert Barrow, CEO of Definium Therapeutics, which is developing an LSD-based therapy, told Reuters that the hearing offers "a nice opportunity for that continuing public dialogue" among regulators, clinicians and patients.
He said regulators and industry should treat psychedelics "like it's normal drug development, normal science, normal medicine," rather than as an unusually novel category requiring special treatment.
Just days before the hearing, senior FDA officials, including Michael Davis, head of the agency's Center for Drug Evaluation and Research, published a paper in the New England Journal of Medicine outlining a framework for developing and approving psychedelic drugs and saying the agency was "meeting this moment" on hard-to-treat conditions such as major depressive disorder and PTSD.
The American Psychiatric Association said it "appreciates the FDA's public hearing and coordination with federal partners on the potential therapeutic use of psychedelics."
"The FDA's determination of safety and effectiveness... must remain the foundation for any future clinical use."
Jefferies analysts said the framework suggested the FDA was willing to consider flexible trial designs to address challenges including "functional unblinding," when a drug's noticeable psychoactive effects reveal to participants which treatment they received.
The administration's support has stirred fresh investor interest in the sector, with industry executives telling Reuters it could improve coordination between the FDA and the Drug Enforcement Administration and help reduce regulatory delays, even as researchers noted that approved treatments were still likely years away.
Continued alignment among regulators, clinicians and developers on a safe, supervised rollout should benefit AtaiBeckley ATAI.O, Compass Pathways CMPS.O, Definium Therapeutics DFTX.O, Helus Pharma HELP.NLB, HELP.O and GH Research GHRS.O, analysts said.
Helus CEO Michael Halstead said "the science continues to advance, and continued thoughtful engagement among regulators, researchers and clinicians is critical to advancing these promising new treatments."
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