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Evidence is mounting that psychedelic drugs can help treat diseases. Here are the most promising uses

Evidence is mounting that psychedelic drugs can help treat diseases. Here are the most promising uses

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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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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.

Read more of our psychedelic medicine coverage:

A Peter Thiel-backed startup has raised $25 million to unleash a ‘virgin market of for-profit psychedelic research’

A Peter Thiel-backed startup has raised $25 million to unleash a ‘virgin market of for-profit psychedelic research’

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  • A new biotech startup backed by Peter Thiel has raised $25 million to study the effects of psychedelics like psilocybin, the active ingredient in magic mushrooms, on depression.
  • Called Atai Life Sciences, the company owns a large stake in another Thiel-backed startup called Compass Pathways.
  • German entrepreneur and investor Christian Angermayer will head up Atai with a focus on studying and producing psychedelics for mental health.
  • Angermayer also has plans to study drugs designed to fight aging and extend life.

In June, an under-the-radar startup backed by Silicon Valley tech mogul Peter Thiel made enough psilocybin – the active ingredient in magic mushrooms – to send 20,000 people on a trip. It was part of a larger effort by the company, called Compass Pathways, to study how psychedelic drugs could be used to treat depression.

It was just the beginning.

On Wednesday, German entrepreneur and Compass investor Christian Angermayer launched a new startup focused exclusively on studying and producing psychedelic drugs for mental illness. Called Atai Life Sciences, the initiative has already raised $25 million from investors like Thiel, ex-hedge fund manager Mike Novogratz, and film producer Sam Englebardt. Atai also owns approximately 25% of Compass.

Alex Tew and Michael Action Smith, founders of the popular meditation app Calm, also invested. Former National Institutes of Health director Tom Insel, who previously served as an advisor to Compass, will stay in that role.

Compass laid the foundation for Atai’s work on psychedelics, which will now be expanded to more studies and potentially more drugs. It raised an additional $33 million as part of the latest funding round, bringing its total to more than $38 million.

Earlier this summer, Compass received regulatory approval to begin one of the first large studies looking at the effect of psilocybin on treatment-resistant depression, a severe form of the illness that does not respond to other medications. Compass also secured a patent on a form of the drug that it makes in a lab.

Atai and Compass are already the world’s leading producers of psilocybin for research, Angermayer told Business Insider. He hopes the new initiative can catalyze a “virgin market of for-profit psychedelics.”

In other words, Atai might create a medical pathway for psychedelics similar to what the marijuana industry has seen in recent years.

In addition to its work on drugs for mental health, Atai will also study treatments designed to fight aging and extend life, Angermayer said. To do so, the company is partnering with German-based Innoplexus, which uses AI to develop drugs.

A resurgence of psychedelic research

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Reuters/ DEA

Psilocybin has become a promising candidate for anxiety and depression treatment because it appears to disrupt the sorts of engrained brain activity patterns that are the hallmark of those diseases. One recent study looked at the compound’s potential to help alleviate anxiety in cancer patients; others have looked at psilocybin’s potential effect on depression, PTSD, and alcoholism.

Compass Pathway’s study, which got FDA approval in August, looks at the effect of three different doses of psilocybin (1 mg, 10 mg, and 25 mg) on treatment-resistant depression. A “standard” dose of dry magic mushrooms is roughly 2 grams, or about 20 mg pure psilocybin, according to nonprofit educational organization Erowid. The clinical trial involves 216 people enrolled across several research sites in Europe and North America.

The magic mushroom isn’t the only psychedelic drug getting renewed attention. There’s been a steady trickle of scientific research on psychedelic drugs’ potential therapeutic benefits for at least the last five years.

A study in 2017 indicated that ecstasy could help veterans cope with PTSD symptoms; one in 2012 hinted that ketamine might curb major depression. That spate of research finally seems to be leading to the development of promising potential treatments that could get government approval.

David Nutt, the former chief drug advisor for the British government and a current advisor to Compass Pathways, is optimistic about the federal approval process. He told Business Insider last year that he expects to see psilocybin approved as a treatment for depression by 2027.

Capitalism comes to psychedelics?

Not everyone is thrilled about the idea of a for-profit company leading the research on psychedelics. So far, the bulk of work in the field has been pioneered by researchers and nonprofits. Now that could change.

“Is this going to be the Eli Lilly of psychedelics? No one ever imagined that,” Charles Grob, a professor of psychiatry at the University of California, Los Angeles and an author on one of the first studies of psilocybin in cancer patients, told Business Insider. Grob is also affiliated with the nonprofit research institute LA Biomed.

“Capitalism comes to psychedelics? I don’t know what kind of fit that will be,” Grob said.

Angermayer thinks the results of his company’s studies will speak for themselves. He estimated that by the time the clinical trial results come out in the fall of 2019, it won’t be more than two years until psilocybin becomes the first medically-approved psychedelic for depression.

“After that, there will be no doubt” that the drug works to treat depression, he said.

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