FDA Grants Quick Review For 3 Psychedelic Drug Trials
Source: Slashdot
The Food and Drug Administration (FDA) has granted expedited reviews for three experimental psychedelic drugs targeting major depression and post‑traumatic stress disorder (PTSD). This move reflects a shift in policy toward treatments that may also produce a “high,” coming shortly after the Justice Department announced it would ease restrictions on state‑licensed medical marijuana.
Companies Receiving Expedited Review
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Compass Pathways (UK) – Received an expedited review for its synthetic psilocybin formulation intended for treatment‑resistant depression. The company cited two large Phase 3 studies that have generated positive data.
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Usona Institute (Wisconsin, USA) – Awarded a priority review voucher for its psilocybin program aimed at major depressive disorder. A spokesperson noted that the review process is expected to take one to two months after the application is submitted. The voucher speeds up the timeline but does not alter scientific or regulatory standards.
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Transcend Therapeutics (New York, USA) – Granted a priority review voucher for its experimental drug methylone for PTSD. CEO Blake Mandell highlighted the ongoing scientific uncertainties surrounding the treatment.
“When you see something that looks promising for a community that is suffering with mental health illness, despair and suicidal ideation, you can’t help but recognize that,” said FDA Commissioner Marty Makary.
Timeline and Outlook
Marty Makary told NBC News that, using the priority voucher program, the FDA could potentially approve the first psychedelic drug by the end of summer.
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