FDA fast-tracks psilocybin-based CYB003 for depression

The FDA continues to signal openness to psychedelic-based therapies. Following its recent Breakthrough Therapy Designation (BTD) for a potential LSD-based anxiety treatment, the agency has extended the same status to Cybin Inc.‘s CYB003 for major depressive disorder (MDD). The move marks the first FDA Breakthrough Therapy Designation for an adjunctive, psychedelic-based Major Depressive Disorder treatment. This move expedites CYB003’s review process and provides increased FDA guidance throughout development.

“I think there’s a positive attitude at the FDA,” said Doug Drysdale, CEO of Cybin. He noted that a significant number of agency representatives attended their end of Phase 2b meeting, indicating strong interest across departments. “They seem excited about the potential of these new treatments.”

FDA’s Breakthrough Designations for psychedelic and MDMA therapies

The FDA has previously granted Breakthrough Therapy Designation (BTD) to psiloc…

Read more
  • 0