Psilocybin - end-of-life distress application (Delays and decision-making)

Question

1. What is the current status of the application that was lodged in March 2025 to extend the rescheduling of psilocybin to include treatment for end-of-life distress? 2. Can the TGA explain the cause of the delay in issuing the interim decision? 3. What weight has been given to clinical trial data, including Australian trials such as the St Vincent's Hospital end of life trial and the New York University and Johns Hopkins end of life trials, in assessing this application?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002761.pdf (opens in a new tab)