In 6 months (around June 2024) the FDA (US medicine regulator) will likely approve MDMA (ecstasy) as a licensed medicine in the US. This will present a pivotal moment for mental health care around the world as the efficacy rates of MDMA relative to traditional treatments for PTSD, depression and addictions are impressive.

As you can see from above, the most recent data indicates high rates of remission from PTSD (red) with MDMA in comparison to placebo (blue). Further comparing these rates (see picture below) to traditional antidepressant effectiveness rates i.e. from 19 to 70% within SSRIs (Prozac et al.), from 31 to 70% within the SNRI (Duloxetine et al.) treatment arms, and from 23 to 54% within TCAs (Amitriptyline et al.).

This may not seem very impressive, however, there is one major distinction, MDMA is curative. The importance of this cannot be stressed enough. Aside from the cost of having to take traditional antidepressants every day which comes with a wide range of side effects, such as with, TCAs treatment: dry mouth (58%), sweating (28%) and constipation (26%)² there’s the additional burden of anhedonia (not being able to feel anything good, or bad!).

MDMA is different. The medicine treats the root cause of the disease instead of just tranquilising the symptoms such as poor mood or lack of motivation. MDMA does this through a process known as fear memory extinction, which modulates fear memory consolidation. At its simplest, this means MDMA can dissolve bad feelings associated with a memory which in extreme cases is termed trauma. This makes it more comparable to traditionally stronger, last-line treatments like ECT which has its major side effects of memory loss.

When will MDMA be available in Australia?

Well in theory, due to the changes put forth by the TGA on 1 July 2023, it should already be available. However, due to the huge amount of red tape and high demand, the vast majority of 1 in 7 depressed patients in Australia cannot get access. This is why the licensing by MAPS is so important, it puts the medicine in a licensed category meaning, that doctors will have better coverage by indemnity insurance if something were to go wrong, therefore, they will have a higher propensity to prescribe. i.e. the risk to them is a lot lower and therefore, given the demand this should cause an upsurge in supply.

So where to go from here? Stay updated with the latest developments. Whilst it’s likely the FDA will license the medicine in the US in June, it will take a bit of time to come to Australia (usually another 6 months). At this point, it is more than likely it will be considered a Controlled Drug and hopefully be prescribable by regular doctors (however this may be limited to psychiatrists only). By whichever route, it should be available this time next year, for a high price due to the overwhelming demand, this is why we have created the Psychedelic Buyers Club to ensure a lower cost via a bulk buy.

References

¹ MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Published in the Nature Medicine Journal: 10 May 2021: Jennifer M. Mitchell. Accessed on 2 January 2024 via: https://www.nature.com/articles/s41591-021-01336-3

² Tricyclic Antidepressants. Moraczewski J, Awosika AO, Aedma KK. [Updated 2023 Aug 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557791/

³ Remission, dropouts, and adverse drug reaction rates in major depressive disorder: a meta-analysis of head-to-head trials. Review published: 2006. Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. M Machado, M Iskedjian, I Ruiz, and TR Einarson. https://www.ncbi.nlm.nih.gov/books/NBK73259/