The most promising uses of psychedelic drugs that were once illegal

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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.

A type of ecstasy might accelerate PTSD therapy

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DEA

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.

MDMA also recently received a key
federal designation designed to hasten the research and
approval process. Some experts believe the drug will be approved

as early as 2021.

A compound in magic mushrooms is showing promise for anxiety

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Researchers studying
psilocybin, the main psychoactive ingredient in
hallucinogenic mushrooms, have likened its
quick effects on cancer patients to a “surgical intervention”
for depression.

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

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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.

Ketamine is inspiring a handful of novel drugs for depression

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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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