Therapeutic Goods Administration will not declassify magic mushrooms, with strict controls to remain

Psilocybin is the psychoactive ingredient found in wild grown
Psilocybin is the psychoactive ingredient found in wild grown "magic mushrooms" that is being touted as a good alternative treatment for mental illness in a medically-controlled environment. Pictured are wild english forest mushrooms.

Depression and anxiety sufferers will not be able to treat their mental illnesses with psychedelic psychotherapy after the nation's medicine regulator ruled against an attempt to downgrade restrictions on magic mushrooms.

But the regulator did not rule out the use of psilocybin - which is the active ingredient in magic mushrooms - for future treatment of mental illness, stating that more research was necessary to prove that it was "safe and efficacious".

Pychedelic psychotherapy proponent Mind Medicine Australia applied last year to the Therapeutic Goods Administration (TGA) to have psilocybin declassified so that the drug could more easily be used in research to treat depression, anxiety, PTSD and end-of-life distress.

It argues that psilocybin-assisted psychotherapy sessions would offer another treatment option to mental illness sufferers where current pharmaceutical treatments do not work.

The risks of developing psychosis, especially in vulnerable populations, must be established in a clinical trial setting...Psilocybin, when misused, can cause psychosis.

Therapeutic Goods Administration interim decision

The psilocybin would be administered by trained specialists in a medically controlled environment in psychotherapy sessions that last between six to eight hours.

In its interim decision published today the TGA said it would not be rescheduling psilocybin from a prohibited substance to a controlled substance due to the unknown side effects and risks of using such a drug.

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It ruled that there are emerging benefits to the use of psilocybin to treat some mental illnesses in a controlled environment, but that the long term and unknown side effects presented too much risk.

"There is limited but emerging evidence that psychedelic therapies may have therapeutic benefits in the treatment of a range of mental illnesses. These benefits are currently under investigation in clinical trials," it wrote.

Psychedelic psychotherapy sessions have been found to provide relief to sufferers of depression, anxiety and other end of life illness distress in some clinical trials.

Psychedelic psychotherapy sessions have been found to provide relief to sufferers of depression, anxiety and other end of life illness distress in some clinical trials.

But added that "the risks of developing psychosis, especially in vulnerable populations, must be established in a clinical trial setting. [It] can cause tachycardia and transient increases in blood pressure. Psilocybin, when misused, can cause psychosis".

The TGA delegate said that the attempt to down-schedule the drug was premature, where only 11 phase II trials have been carried out and no phase III trials have begun.

"In making my decision, I have taken into account the two 'Breakthrough Therapy Designations' that have been granted by the U.S. Food and Drug Administration. I note that, while these designations indicate that the therapy shows promise, they do not equate to FDA approval.

"Currently no comparable country has down-scheduled psilocybin to a category equivalent to Schedule 8, and at present, there is no international framework for how to handle psychedelic assisted therapies."

The TGA said there are benefits to waiting for the results of clinical trials.

"Psilocybin assisted psychotherapy may eventually prove to be safe and efficacious, but the evidence does not yet suggest this," it wrote.

"It will take years to develop a curriculum and accredited training process for psychiatrists. To protect public health and prevent misuse, psilocybin should not be down-scheduled until all necessary safeguards have been established and implemented."

This story Psychedelics will not be used to treat depression, "too many risks" says TGA first appeared on The Examiner.