Emyria will expand its MDMA programs after the TGA announced a decision to downschedule MDMA and psilocybin to Schedule 8 controlled substances.
While the TGA was deliberating, Emyria:
- established a network of clinical partners
- developed a supply chain for Schedule 8 and 9 medicines
- identified numerous suppliers of GMP-MDMA (“patient-ready”) and;
- developed a comprehensive Phase 2B clinical trial protocol for MDMA-assisted therapy.
“The mental health crisis – in Australia and around the world – continues to have untold cost, which is why the TGA’s move to reschedule MDMA and psilocybin is timely and world-leading,” said Emyria Managing Director Dr Michael Winlo.
“Emyria is well-prepared to support the safe provision of MDMA-assisted therapies under this new change as the only ASX company with a clinical service specialising in unregistered medicines and Real-World Data generation. Emyria has also developed a comprehensive MDMA-assisted therapy protocol that can now support specialists.”
More information at our investor hub: Emyria expands MDMA programs following landmark TGA decision | Emyria Investor Hub