Once portrayed as illegal ways to “drop out” or “tune in,” psychedelic and semi-psychedelic drugs like psilocybin and ecstasy are finally starting to turn into federally-regulated medicines.
The tide began to turn over the summer, when a little-known startup backed by Silicon Valley tech mogul Peter Thiel churned out enough of the active ingredient in magic mushrooms to send 20,000 people on a psychedelic trip. It was part of a larger research effort by the company, called Compass Pathways, to study how psychedelic drugs could be used to treat depression.
It was only the beginning. Earlier this month, a German entrepreneur launched a new company called Atai Life Sciences with $25 million to back more studies that explore the therapeutic potential of psychedelic drugs on psychiatric disease. And last week, federal regulators deemed psilocybin worthy of “breakthrough status,” a designation designed to speed the drug approval process for treatments that serve unmet needs.
MDMA, better known as ecstasy, nabbed that designation last year. Just this week, researchers published a new study that suggested MDMA could help people dealing with post-traumatic stress disorder (PTSD).
Prior to the recent wave of research, the study of psychedelic substances — many of which remain officially recognized as Schedule 1 drugs with no legal medical use — was nearly impossible. But in recent years, the efforts have begun to make headway.
The obvious psychedelic suspects aren’t the only drugs in the realm that are turning into medicines. The first prescription drug made with marijuana, which many experts consider a psychedelic in high enough doses, was green-lit by U.S. federal regulators in June.
On Monday, researchers published the latest findings of a year-long study designed to assess if MDMA could play a role in treatment for PTSD. Their positive findings suggest that it could.
After the treatment, in which patients were given MDMA alongside traditional talk therapy and compared with a group that got the same treatment only using a placebo instead of the drug, some three-quarters of the participants no longer met the criteria for a PTSD diagnosis. In other words, their symptoms had resolved.
That’s a significant result. One of the chief problems with current talk therapy is that even when patients are able to afford and access the treatment, they grow tired of the painful process of rehashing traumatic events and sometimes disappear for months on end, according to psychiatrist Julie Holland, who currently serves as a medical observer for the MDMA study.
Still, the treatment was tied to some unpleasant side effects including insomnia, tiredness, and headaches. The drug, which amps up the activity of chemical messengers involved in mood regulation, can be dangerous when used without medical supervision because it raises body temperature and blood pressure.
Brain scan studies suggest that depression ramps up the activity in brain circuits linked with negative emotions, and weakens the activity in circuits linked with positive ones. Psilocybin appears to restore balance to that system.
Two for-profit companies are currently leading the research in the space. The first, called Compass Pathways, is backed by entrepreneur Peter Thiel and has plans to start its own clinical trials of magic mushrooms for depression later this year. The second, a biotech startup launched last month called Atai, is focused on financing more of the kind of research that Compass is doing. Atai has already raised $25 million from investors like ex-hedge fund manager Mike Novogratz and Icelandic entrepreneur Thor Bjorgolfsson.
Some researchers have high hopes that a psilocybin-inspired drug will get approved within a decade. David Nutt, director of the neuropsychopharmacology unit at Imperial College London, told Business Insider last year that he believed psilocybin would become an “accepted treatment” for depression before 2027.
The first prescription drug made from marijuana won federal approval this summer.
Called Epidiolex, the drug is designed to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).
British-based GW Pharmaceuticals makes the drug. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug’s characteristic high.
The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds to treat other psychiatric and neurological diseases.
A widely used anesthetic that is also known as a party drug, ketamine was shown to have benefits as a rapid-fire antidepressant nearly a decade ago. Early studies suggested ketamine could help people who failed to respond to existing medications or were suicidal.
The authors of one paper called ketamine “the most important discovery in half a century.”
As opposed to existing antidepressants, ketamine acts on a brain mechanism that scientists have only recently begun to explore. Homing in on this channel appears to provide relief from depression that is better, arrives faster, and works in far more people than current drugs.
After a lack of new drugs for depression spurred scientists to go back to the drawing board, pharmaceutical companies like Allergan and Johnson & Johnson are now in hot pursuit of new blockbuster depression drugs that take after ketamine.
Allergan’s drug is in the last phase of clinical trials and has received a key FDA designation designed to speed it through the approval process. A Johnson & Johnson spokesperson told Business Insider that it expects to file for FDA approval of its drug — a nasal spray made with the chemical mirror image of ketamine — this year, despite what some experts have called disappointing results from a study done in its most recent phase of research.
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