Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA

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Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA

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Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA


Rich Haridy
October 24th, 2018

Granting of Breakthrough Therapy status allows the FDA to expedite research and review of psilocybin-based treatments...

Granting of Breakthrough Therapy status allows the FDA to expedite research and review of psilocybin-based treatments to move them into clinical use sooner
(Credit: Vox19/Depositphotos)

In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant potential in early clinical evidence, allowing the FDA to assist and expedite subsequent development and review processes.

The FDA's Breakthrough Therapy designation was created in 2012 as a way of presenting a faster pathway to approval for drugs that display treatment advantages over current options for serious or life-threatening conditions. While not all Breakthrough Therapy treatments may ultimately prove efficacious and make it to market, the designation is generally a positive thumbs-up from the FDA that it's potentially useful and should be expedited.

The specific designation in this instance is directed at a phase IIb trial currently underway across Europe and North America. The research is investigating the optimal dose range for psilocybin in regards to severe treatment-resistant depression. Prior research has found that one to two doses of the psychedelic agent, administered in controlled settings, can markedly reduce a person's depressive symptoms. The safety of these treatments has also been established through earlier research.

The multi-center clinical trial now underway is being run by life sciences company COMPASS Pathways and expands on decades of work by researchers around the world who toiled to push this previously taboo drug into the light of legitimate medical research. Robin Carhart-Harris, head of the Psychedelic Research Group at Imperial College London, has been working for several years to establish the efficacy of psilocybin treatment for depression, and notes that this new FDA designation is a positive sign for the future of psychedelic drug therapy.

"The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy," says Carhart-Harris. "We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-center trial."

One of the interesting looming implications of psilocybin's acceleration towards legitimate medical use is that if it passes phase III clinical trials the FDA will be forced to recommend a change to the drug's restrictive Schedule 1 control. Schedule 1 is the most restrictive category of drug control in the United States, essentially establishing the substance as highly addictive and having no medical benefit. This kind of oppressive classification limits the breadth of research into potential beneficial uses for specific drugs.

Marijuana has been the drug under the most scrutiny in recent times regarding its strict scheduling. Following the landmark approval of Epidiolex, the first ever medicine approved in the United States from a marijuana-derived compound, the FDA was challenged to recommend rescheduling marijuana, or at the very least cannabidiol (CBD), the primary compound derived from the plant. While the DEA is the US government agency ultimately in control of scheduling drugs, it generally acts on recommendations from the FDA once a certain compound reaches general approval stages. Ultimately the DEA refused to drop either marijuana or CBD from its restrictive Schedule 1 classification, instead contorting itself to limit the rescheduling to Epidiolex specifically and not anything broader.

This psilocybin therapy, on the other hand, poses a more complicated scenario for the FDA, and other relevant United States authorities. Much like the pathway being forged with MDMA for PTSD, the demonstrable clinical benefits of the substance make it impossible to keep it restricted to Schedule 1, especially if it successfully moves through phase III clinical trials.

Researchers working with psilocybin from Johns Hopkins recently penned a comprehensive article suggesting the drug needs to be rescheduled down to Schedule IV. The article outlined a raft of evidence highlighting the potential therapeutic benefits of the drug, as well as its proven low rates of abuse, and demonstrable lack of physical dependence potential.

"We should be clear that psilocybin is not without risks of harm, which are greater in recreational than medical settings," says Matthew Johnson from Johns Hopkins, "but relatively speaking, looking at other drugs both legal and illegal, it comes off as being the least harmful in different surveys and across different countries."

This latest step from the FDA, to offer psilocybin a Breakthrough Therapy designation, is a quietly extraordinary move from the federal agency, implicitly suggesting this previously stigmatized drug may have beneficial clinical uses. And, if all continues along the same path, within the next five years a significant psychedelic drug, that has been restricted for decades, may become more available for clinicians and medical researchers to work with.


Editor's note (October 25, 2018): This article was edited to clarify the relationship between the DEA and the FDA in regards to how a drug can be reclassified.

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'Magic mushroom' ingredient could work as mental health treatment

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While magic mushrooms are known for their hallucinogenic effects, they may also have a role to play in the treatment of some mental health treatment.

Or they might, if they weren't illegal in most states.
Oregon has become the first US state to make psilocybin, the hallucinogenic compound in magic mushrooms, legal for mental health treatment in supervised settings.
They have more evidence for their case with a new small study of 24 adults with major depression that published this week in the journal JAMA Psychiatry, which found that two doses of psilocybin led to a large reduction in depressive symptoms.

"The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market," said Alan Davis, an adjunct assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, in a news statement.
"Because most other depression treatments take weeks or months to work and may have undesirable effects, this could be a game changer if these findings hold up in future 'gold-standard' placebo-controlled clinical trials."

While not without limitations, the study is the latest research to explore how psilocybin could help ease mental health problems. Other studies have suggested that the compound may help in the treatment of anorexia, obsessive-compulsive disorder and addictions.
The participants in the John Hopkins study had experienced depression for around two years before being recruited and had to give up existing antidepressants. Thirteen participants received the psilocybin treatment immediately after being enrolled, and 11 participants were put on a waiting list and received the same treatment after an eight-week delay.

The study offered more evidence of psilocybin's "rapid and powerful effect," said David Nutt, a professor and director of the neuropsychopharmacology unit in the division of brain sciences at Imperial College London. The results could have been skewed by the fact that patients knew they were going to get the drug, with expectations potentially increasing the size of the effect, said Nutt, who wasn't involved with the research.
A 2016 study conducted by some of the same John Hopkins researchers found that psilocybin could ease depression and anxiety in patients who had life-threatening cancer.

"Because there are several types of major depressive disorders that may result in variation in how people respond to treatment, I was surprised that most of our study participants found the psilocybin treatment to be effective," said Roland Griffiths, an author of the new study and the 2016 paper, and a professor at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Center for Psychedelic and Consciousness Research.
Psilocybins can produce visual and auditory hallucinations and profound changes in consciousness over a few hours after ingestion, the study said.
In the United States, possession of the compound is a felony, as they are classified as a Schedule I substance.
The vote in Oregon requires the Oregon Health Authority to allow licensed, regulated production and possession of psilocybin, exclusively for administration by licensed facilitators to clients.

How it might affect the brain
How psilocybin affects the brain still isn't completely understood, but Nutt at Imperial College said that it appeared the compound disrupted negative thinking circuits through the 5HT2Z receptor in the brain.
"Standard anti-depressants protect against the stressors that lead to and perpetuate depression but don't directly access and remedy underlying biopsychosocial causes," he wrote in a paper he coauthored and published earlier this year.

"In contrast, psychedelic therapy harnesses a therapeutic window opened up by the brain via the effects of drugs to facilitate insight and emotional release."
He said that the substance tended to work with "internalizing disorders" like depression or obsessive-compulsive disorder whereby individuals ruminate on failings or intrusive thoughts.

Another explanation could be more straighforwardly pharmacological, said Guy Goodwin, a professor emeritus of psychiatry at the University of Oxford -- that psilocybin "is just a kick up the backside" of the serotonin system. Serotonin is a chemical and neurotransmitter in the digestive system, brain and blood system that regulates mood, social behavior, appetite, sleep, memory and sexual function.
Goodwin, who wasn't involved with the research, said the main limitation of the John Hopkins study was the absence of longer-term follow-up -- the team followed up with the participants only four weeks after the treatment. Depression for many people is a long-term condition, and determining if the treatment had lasting effects is a key missing factor.

What's more, with studies like these, it can be hard to tease out the effects of the drug from the process of administering it, Goodwin said.
The study participants received about 11 hours of psychotherapy and received the drug under the care of trained professionals and in a setting designed to put the patient at ease.
"You get an effect irrespective of whether the treatment works because everyone is caring for you and looking out for you and measuring things. People like that and feel better for that. In a real comparison you'd do everything the same but the actual drugs."

However, he said that larger studies were underway that should address the questions raised by early proof of concept studies like this one.
"This is a nice, small preliminary study with a lot of weaknesses but equally the positive results promise better things."
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