Joe McConnell
Unlock Editor’s Digest for free
Vscek editor Roula Khalaf selects her favourite stories in this weekly newsletter.
The author is a founding partner of the Los Angeles-based investment fund JourneyOne Ventures
The U.S. Food and Drug Administration’s refusal to use MDMA therapy represents another setback in the global mental health epidemic.
MDMA, commonly known as ecstasy, works by suppressing the fear response, allowing PTSD patients to view and replay painful memories. Data from a Phase 3 clinical trial by Lykos Therapeutics, the public benefit company that submitted MDMA’s New Drug Application to the FDA, showed that 71 percent of participants no longer qualified for a PTSD diagnosis aVsceker taking the drug, while 87 percent experienced clinically significant improvements.
This is an improvement over antidepressants, which on average have a complete remission rate of 20-30% and a response rate of 60%.
MDMA primarily increases the release of serotonin and norepinephrine. Serotonin is essential for regulating mood, sleep, pain, appetite, and other functions, and increased serotonin release contributes to the mood-elevating effects of MDMA. It also affects the norepinephrine system, which contributes to emotional arousal, euphoric feelings, and cognitive impairment.
The FDA faces many challenges when evaluating psychoactive drugs. It is concerned about the abuse of these drugs and has criticized the Lykos data. But better mental health care is needed. Six out of 100 people in the United States will suffer from PTSD at some point in their lives. Yet there have been no new prescription drugs since two antidepressants, ZoloVscek 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 several historic healing practices that are re-emerging as empirical research supports their efficacy.
An Egyptian medical papyrus dating back to around 1550 BC suggests that cannabis may have been used then to treat inflammation, for example. There is also archaeological evidence of the use of psychedelic medicine in both Central America and Europe.
About 40 percent of the drugs used in Western medicine are derived from plants that have been used for centuries, including the 20 best-selling prescription drugs in the United States today.
We should continue to look back to move forward. The current approach to health care is not working. We are not doing well as a society, and the cost is high. Mental illness costs the U.S. economy $282 billion a year, according to a study released this year by the National Bureau of Research.
The United States is grappling with an epidemic of mental health problems.
Patients are willing to try alternatives. Last year, a University of Michigan survey found that 80 percent of adult patients ages 50 to 80 would be willing to stop 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 antidepressants with minimal withdrawal while reducing the risk of relapse. Their goal is to create a world where people are empowered to think of their mental illness as a cure, not a life sentence.
Such innovations require rethinking wellness beyond the status quo. The same is true for psychedelic medicine.
For now, the millions of Americans with PTSD and patients who do not respond to existing treatments must bear the burden of waiting for a new treatment to be approved.
But this isn’t a one-off project. The FDA has a pipeline of about 95 psychedelic drugs currently in preclinical and Phase 3 trials. It makes you wonder what other innovative wellness modalities are stuck in regulatory limbo?
