‘Magic mushroom’ drug receives breakthrough therapy designation

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/ipopba)
(Image: Getty/ipopba)

Related tags: Neurology, psychiatrics, Ketamine, psilocybin, Fda, FDA approval, depression, mental illness

Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.

Compass Pathways, a life sciences company focused on developing new mental health treatments, received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) this week after preliminary clinical evidence showed that it may provide substantial benefits over current therapies.

At this time, Selective Serotonin Reuptake Inhibitors (SSRIs) are the most popular treatment path with individuals suffering from depression. Psilocybin works differently from SSRIs in that it inhibits serotonin-dependent neurons and “resets the brain.”

This designation – which expedites FDA review – is a milestone for research into psilocybin, a psychoactive medicine and one of the two active ingredients in what is often called ‘magic mushrooms.’

Tracy Cheung, strategic communications consultant for Compass told us that in the company’s experience, regulators have given serious consideration to scientific and clinical data rather than focusing on the scheduled status of the substance.

“Our impression is that presently there are no political or ideological barriers to the development of psilocybin therapy and it is about the generation of high quality clinical data that meets regulatory standards,”​ said Cheung.

Regulators have been open to considering new solutions for patients who have limited options, she said.

Cheung also emphasized that the therapy given with the psilocybin treatment is as important to the treatment as the drug. She explained that patients are screened for contraindications, and prepared before, during, and after the psilocybin session by specially trained therapists. 

From proof-of-concept to large-scale trials

The Heffter Research Institute was the first to fund research in the field of psilocybin therapy. Early studies were conducted at Johns Hopkins University, New York University, and Harbor-UCLA.

The Medical Research Council also backed a proof-of-concept study of psilocybin in the UK at the Imperial College London in 2015. The study dosed 19 patients with psilocybin in a clinical setting. The treatment was coupled with psychological support, which led to promising signals of safety and efficacy as a treatment option for individuals with treatment-resistant depression.

“The innovation is being welcomed at a time when the incidence of mental illness is rapidly increasing, depression is the leading cause of ill-health and disability worldwide, and more than 100 million people suffer from treatment-resistant depression,”​ Cheung said.

In August, Compass Pathways received FDA approval ​for its clinical trial, which will be conducted in collaboration with the contract research organization (CRO) Worldwide Clinical Trials in 2019. This trial will occur in Europe and North America over the following year.

Atypical and alternative treatments

Psilocybin is not the only alternative psychiatric treatment currently in development. The once popular club drug ketamine is in clinical trials for treatment-resistant depression​, as well as the treatment of acutely suicidal individuals. These alternative treatments both work on the brain differently than standard treatments.

N-methyl-d-aspartate (NDMA) receptor antagonists have demonstrated potential in the treatment of depression​ with rapid and positive results. Among these are ketamine, esketamine, and AV-101​ – atypical treatments currently in clinical trials.  

These drugs are alternatives to the standard treatment of SSRIs, which can take four to six weeks to fully work, while ketamine can start working within hours.

While it is unknown if atypical drugs are a real possibility for the future of mental illness drug development, what seems to be steadfast is the possibility of finding a solution for those suffering from mental illness, as new research continues to breakthrough.

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