Little Green Pharma approved for psilocybin trial

15 February 2023 10:41

Little Green Pharma is moving into the next stage of its alternative medicine business with its subsidiary Reset Mind Sciences receiving ethics approval to conduct a clinical trial concerning the use of psilocybin to treat patients with treatment-resistant major depressive disorder, the first of its kind in Western Australia.

Approval for the clinical study comes on the heels of the Therapeutic Goods Association’s surprising decision to allow for the use of psilocybin and MDMA as a treatment for patients with treatment-resistant depression and PTSD respectively, with LGP already positioned ahead of the curve with a psychedelic subsidiary ready to move on a global market expected to reach $6.9 billion in value by 2027.

The focus will be placed on the efficacy and safety of including family members of patients with treatment-resistant major depressive disorder in treatment.

The trial will build on the body of global research into the use of psilocybin to treat depressive-related conditions through the incorporation of key family members into the preparatory and integration therapy sessions preceding the psilocybin administration sessions.

Held in cooperation with both the University of Western Australia and Edith Cowan University, the trial is focused on the development and refinement of best-practice psychotherapy protocols to accompany the administration of psilocybin.

“The trial will be one of the first psilocybin-assisted therapy trials in Australia and we trust it will contribute meaningfully to the clinical evidence supporting the use of psilocybin and other psychedelics for the treatment of chronic mental illness in Australia,” Reset Mind Sciences Chief executive Shaun Duffy said.

“Given we are investigating the condition allowed by the TGA for prescription of psilocybin from 1 July 2023, we anticipate the clinical evidence we obtain will be highly instructive in the treatment of patients under the new regime announced by the TGA.”

Recruitment for the trial is expected to start up in the second quarter of this year and run for close to a year.

The TGA’s announcement has seen the LGP’s share price jump 2.43 per cent today, currently trading at 0.21c (10.11 am UTC + hours).

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