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Emyria MDMA clinical trials despite TGA rejecting bid for psychedelic reclassification

Despite the high-profile investments, last month the TGA knocked back a bid to have MDMA and psilocybin (the active ingredient in magic mushrooms) rescheduled from Schedule 9 prohibited substances to Schedule 8 controlled substances.

Although the TGA acknowledged that early trials of MDMA and psilocybin showed promise, it said ensuring the safe administration of the drugs would be difficult to achieve outside a clinical trial framework.

Researchers to push ahead

While some were disappointed with the decision, many said the TGA’s decision would not interfere with the bulk of Australian-based psychedelic research already underway.

“There wasn’t actually a huge expectation it would be downgraded,” said Shaun Duffy, chief executive of Reset Mind Sciences, a subsidiary of ASX-listed Green Little Pharma that focuses on psychedelics.

“People are working hard to advance the treatment and protocols around psychedelics, and those projects aren’t dependent on a reclassification.”

The psychedelic research industry in Australia is primarily concerned with two main areas: growing the drugs, and delivery, which includes researching effective ways psychiatrists can guide patients through a session.

Earlier this month the federal government granted $14.8 million to seven research projects looking at how psilocybin, MDMA, dimethyltryptamine (DMT), and cannabidiol (CBD) could be used to help treat patients who have not responded to other treatments.

The largest grant of more than $3.8 million was awarded to a team at the University of Melbourne for a trial that uses MDMA to help treat social anxiety in young adults with autism.

Other trials will use psilocybin for anorexia, depression and alcohol use; MDMA for alcoholism and post-traumatic stress disorder; CBD for anxiety disorders in youth; and DMT for major depression and alcohol use.

The largest research program in Australia is being undertaken at St Vincent’s Hospital in Melbourne.

The hospital has 40 terminally ill patients receiving psilocybin combined with regular therapy, to see whether it reduces depression or anxiety and produces a substantial positive shift in patients’ perspectives on life and death.

St Vincent’s Hospital in Sydney has also experimented with psilocybin to determine whether it can help people stop or reduce an addiction to methamphetamine.

Led by Dr Matt Piggott, Emyria’s program will examine the effects of the compounds on a range of neurological targets. The most promising of those will advance to a full clinical development program.

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