The writer is founding partner of capital fund JourneyOne Ventures based in Los Angeles
The US Food and Drug Administration’s rejection of MDMA-assisted therapy is yet another setback in the global mental health epidemic.
MDMA, commonly known as ecstasy, works by suppressing the fear response, allowing patients who suffer from PTSD to observe and reprocess painful memories. Phase 3 clinical trial data from Lykos Therapeutics, the public benefit corporation that filed the MDMA New Drug Application with the FDA, showed that 71 per cent of participants no longer qualified for a PTSD diagnosis after taking the drug, while 87 per cent had clinically meaningful improvements.
This is an improvement compared to antidepressants, which on average have a 20-30 per cent complete remission rate and 60 per cent response rate.
MDMA primarily increases the release of serotonin and norepinephrine. Serotonin is crucial for regulating mood, sleep, pain, appetite and other functions, and the increased release of serotonin contributes to MDMA’s mood-elevating effects. It also affects the norepinephrine system, which contributes to emotional excitement, euphoric feelings and cognitive impairment.
The FDA faces many challenges when evaluating psychoactive drugs. It is concerned about abuse of these drugs and has criticised Lykos data. But better mental healthcare treatment is required. Six out of every 100 people in the US will suffer from PTSD at some point in their lives. Yet there have been no new prescription medicines since two antidepressants, Zoloft and Paxil, were approved for this use by the FDA 25 years ago.
MDMA was developed in 1912 by a Merck chemist. It is one of a number of historical healing practices resurfacing as empirical research supports their efficacy.
Egyptian medical papyrus dating back to around 1550BC suggests cannabis may have been used then to treat inflammation, for example. There is also archaeological evidence of psychedelic medicine use in both Central America and Europe.
Some 40 per cent of the drugs used in western medicine are already derived from plants that have been in use for centuries, including the top 20 best selling prescription drugs in the US today.
We should continue to look backwards in order to move forwards. The current approach towards healthcare is not working. We are not well as a society and the cost is high. Mental illness costs the US economy $282bn a year, according to a study published this year by the National Bureau of Research.
The US is in the grip of a mental health epidemic.
Patients are ready to try alternatives. Last year, a University of Michigan survey found that 80 per cent of adult patients aged 50-80 would be open to stopping one or more of their long-term medications if a doctor said it was possible.
The problem is that once people are on these drugs, withdrawal can be severe. Frontier wellness companies like Outro have developed “hyperbolic tapering”, a process to help people get off of antidepressants with minimal withdrawal while reducing the risk of relapse. Their objective is to create a world where people are empowered to think about their mental illness as recovery, not a life sentence.
Such innovations require reimagining wellness beyond the status quo. So does psychedelic medicine.
For now, the millions of Americans with PTSD and the patients who aren’t responsive to existing treatments have to bear the burden of waiting for new treatment to be approved.
But this is not a one-off project. The FDA has a pipeline of around 95 psychedelic drugs currently in pre-clinical to phase 3 studies. It makes you wonder what other ground breaking wellness modalities are stuck in regulatory limbo?