Breakthrough Therapy Status

Psilocybin has recently been designated “breakthrough therapy status” by the FDA in order to expedite its development into a pharmaceutical medication to treat Treatment resistant Depression (TRD) and Major Depressive disorder (MDD).

Psychedelic therapy will soon be offered in Australia under variations of these 3 schemes: 
 

  • the Special Access Scheme (SAS), which requires TGA approval for each patient prior to the approval of a psychedelic therapy session.

  • the Authorised Prescribers (AP) scheme, where specific doctors are authorised to supply the product to patients in their direct care, without separate TGA approval being required for each patient; and

  • by researchers under a clinical trial protocol.

The Therapeutic Goods Administration (TGA) hasn't fully consolidated on how medicinal psychedelics can be used in Australia but an increasing number of indications such as Treatment Resistant Depression (TRD), Massive Depressive Disorder (MDD), End of Life Anxiety, Alhzeimers and Dementia, Post Traumatic Stress Disorder (PTSD)  Obsessive Compulsive Disorder (OCD), chronic pain, stroke victims and for palliative care patients are potential indications on the horizon with further research.

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Our goal is to harmonize with the TGA and deliver evidence based outcomes for difficult to treat neurological disorders through variations of previous initiatives.

We believe that the general population have a right to access any medicine which shows proven clinical benefit and have passed rigorous safety tests. We do not advocate for non-clinical use of psychedelics, MDMA, or any other prohibited substances, nor do we advocate for any changes to the law with respect to non-clinical use. Our focus is wholly clinical.

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