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Emyria to expand MDMA programs following landmark TGA decision

Emyria to expand MDMA programs following landmark TGA decision

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

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