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Psychedelic treatments for mental health – is US approval in sight?

News analysis by Susannah Hollywood

The movement behind psychedelics as a mental health treatment continues to gather momentum – and new evidence in the US will increase pressure on regulatory bodies to license them

Psychedelics are still currently illegal under federal law in the US. However, a scattering of US cities and counties have decriminalised their use in recent years. Oregon and Colorado have gone further, both legalising use of compounds such as psilocybin (the psychedelic ingredient in magic mushrooms) in certain settings, state-wide.

Psilocybin is a psychedelic substance which can alter perceptions of reality, influencing moods and emotions, skewing sensory inputs and even causing hallucinations. Despite being illegal in the US, it is taken recreationally for the positive effects of this altered state of consciousness.

Used therapeutically, it is thought to increase the brain’s neuroplasticity, its ability to re-organise itself, form new connections and re-wire pathways.

This enhanced state of neuroplasticity has significant therapeutic potential in psychiatric conditions where perspectives and thought patterns have become narrowed, hard-wired or inflexible. The psychedelic therapy acts as a disruptor, opening up pathways, allowing past experiences to be reframed and perceptions to be changed. The drugs are usually given in conjunction with psychotherapy in order to optimise the new pathways and patterns established.

Currently only a few locations in the US have made these ground-breaking moves to decriminalise psychedelic use in therapeutic settings. However, the push to gain wider regulatory approval is gathering steam.

Results from a recent clinical trial investigating use of MDMA (the psychedelic commonly known as ecstasy) in conjunction with psychotherapy in the treatment of post-traumatic stress disorder (PTSD) have shown clear efficacy.

It was the second trial to show such positive results with MDMA in this condition, and the researchers responsible can now directly seek approval for this therapy from the US Food & Drug Administration (FDA), the regulatory body responsible for the evaluation and licencing of drug treatments. A decision may be made as soon as next year.

The FDA has already granted both MDMA and psilocybin the designation of ‘breakthrough therapy’; MDMA for PTSD, psilocybin for use in treatment-resistant depression and major depressive disorder. This FDA categorisation is reserved for use in serious conditions and for treatments that are showing potential for a significant improvement on those currently available. It helps to fast track the review and approval process.

FDA approval would be a milestone. Overcoming this regulatory hurdle would open the door to a wider roll-out of these therapies to the general public and could potentially unlock federal funding for further trials.

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Evidence of clear efficacy is starting to emerge in this field, increasing pressure on lawmakers to consider the benefits versus the risks of change. As the prospect of approval of these drugs on a wider scale improves, commercial interest in this area heats up with companies involved in the study and potential future manufacture of these compounds looking at ways of improving their products to make them more accessible to a wide range of people.

One downside to current treatment is the time that it requires. The effects of psilocybin, for example, usually last around 6 hours and treatment with this drug is carried out at a licenced clinic under supervision. This makes it an expensive and resource-intensive treatment option. It is currently not reimbursed by health insurance policies in the US.

Biotech firms working in this field are investigating whether treatment time can be reduced whilst maintaining efficacy. Shorter-acting psychedelics are being studied, along with the possibility of replacing oral administration with intravenous to speed up absorption of the drug into the bloodstream.

Another area of research is into non-hallucinogenic psychedelics. Researchers hope that these compounds would require less supervision during administration but would be no less effective.

Reducing the duration of each session and the requirement for supervision could improve both convenience and costs, which could lead to the treatment being available to more people.

There is debate amongst researchers in this field, however, about whether these adaptations are possible whilst maintaining therapeutic benefits.

Associate professor of neuroscience at Johns Hopkins University in the US, Gül Dölen, is a researcher in the field of psychedelics. Professor Dölen believes that the duration of enhanced neuroplasticity of the brain is directly related to the length of the trip. She warns that shortening its duration, as well as removing the hallucinogenic component, will “probably interfere with the therapeutic effect”. Research is ongoing in this area.

What does this mean for the UK?

To date, no psychedelic treatments have received approval for use in the UK. For this to change, these compounds would need to undergo review and licencing by the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA).

Following MHRA approval, a second evaluation for cost-effectiveness would be required by the National Institute for Health and Care Excellence (NICE) for treatments to be made available on the NHS.

The UK’s stringent drug laws currently keep psychedelics strictly illegal for use in any setting. Legal status and funding for research go hand-in-hand, and this lack of acknowledgement of emerging evidence is frustrating to UK supporters of these therapies.

Mental health is an area of significant unmet need in the UK, with considerable economic and societal impact, and ways to improve treatment provision are continuously being investigated. Some experts believe that thinking outside the box to consider therapies such psychedelics is the way forward.

Professor David Nutt, Psychiatrist and Psychopharmacologist and a leading researcher globally in this field, is one such advocate. Professor Nutt believes that psychedelics are the “biggest breakthrough in mental health in 50 years” but that, despite this, legal and regulatory restrictions in the UK are hampering research and that an overall change in mindset is needed.

Progress in this area in the UK may come from recent policy changes. Earlier this year, guidelines were established for a fast-track approval process by UK regulators for healthcare treatments approved by trusted bodies in other countries, including the FDA in the US.

This should mean that drugs approved for use in countries like the US will automatically be on an accelerated route for approval in the UK. Given recent advancements in psychedelic therapy research in the US, this could be positive news. However, whether these new rules would apply to this progressive, but controversial, field remains to be seen.

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