Psychedelic treatments have been considered for the treatment of mental health since the 1950s, following the development of lysergic acid diethylamide (LSD-25) by Albert Hoffman in 1938. Government intervention and regulation throughout the 1970s slowed potential medical development, but recent successful clinical trials have shown that mind-altering substances are particularly effective in treating depression, anxiety, and post-traumatic stress disorder ( They suggested that the study could offer opportunities for treating mental health conditions such as PTSD (PTSD), eating disorders, and substance abuse disorders.
Psychedelic treatments: current uses and potential
Although psychedelics are well established, the use of mind-altering drugs in the treatment of mental health is still in its infancy. Development is hampered by public perception and timelines. However, recently there has been a movement toward more widespread adoption of psychedelic therapy.
Australia became the first country to down-schedule the medical use of MDMA and psilocybin in July 2023, while in the US, esketamine, a form of ketamine, was approved by the Food and Drug Administration (FDA) in 2019 as a treatment for depression. approved as. It is also used in mental health treatment in the UK and is classified as Schedule 2. This means it can be prescribed by doctors and pharmacists, legally possessed and supplied, and researched without a controlled substance license.
GlobalData analyst Adam Bradbury explained how ketamine became popular in the mental health field: Both the US and the EU. Esketamine is derived from the anesthetic ketamine. Its sales have grown significantly to $689 million in 2023 ($224 million in 2021), and clinical trials have shown that it is effective, with symptoms reduced by at least 50% in about 70% of patients. It has been. ”
London-based Awakn Clinics uses ketamine-assisted therapy to treat mental health and addiction. said Matt Riveras, consultant psychiatrist and group psychotherapist. pharmaceutical technology About the effects of medicine.
“We tend to find that this therapy helps people who have been suffering for a long time and have long-term depression where other approaches have not worked. People who come to us with these kinds of problems About two-thirds of people improve. Two areas that are particularly helpful are alcohol use issues and trauma-related issues, where we have had great success in helping people with PTSD.”
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He continued: “The million dollar question is, ‘Is what we’re doing leading to long-term change in people?'” In the short term, you can be sure that people are benefiting. Also, if people can make changes in the short term, they can take advantage of that period to get into a better state of mind, changes that will help them in the long term. ”
Successful trials are attracting investor interest
The Awakn Clinics study is partially informed by research conducted at the University of Exeter considering the effectiveness of ketamine in treating alcohol dependence.was announced on American Journal of Psychiatry, The study included 96 participants with alcohol problems. Patients who received the combination of ketamine and treatment achieved an 87% abstinence rate and were 2.5 times more likely to remain abstinent after the trial than those who received a placebo.
This study was important in informing potential future uses of ketamine. However, Professor Liberas cautioned that “conducting randomized controlled studies of ketamine-assisted psychotherapy is much more difficult because it is much more difficult to set up control situations.” Psychotherapy is much more difficult to pinpoint and pinpoint what is going on than when using a single probe. ”
Other psychedelic drugs have also had some success in treating mental health and are attracting investor interest. In 2023, MAPS announced positive results from a confirmatory phase 3 trial of MDMA-assisted therapy for the treatment of PTSD (MAPP2). The results showed that 71.1% of patients who received three sessions of MDMA-assisted therapy no longer met diagnostic criteria for PTSD, compared with 47.5% of those in the placebo group.
The MDMA-assisted therapy is currently under FDA priority review and, if approved, could be rescheduled by November 2024. This outlook is attracting interest from the following investors: Biotechnology venture capital fund Negev Capital. His partner, Ken Belotsky, explained where the interest lies.
“These approvals, combined with other Phase I and Phase II trials currently underway, will enhance the reputation of companies developing precision psychedelic-based psychiatric drugs. 2023 Today, more than 36% of FDA-approved clinical trials of depression drugs used psychedelics, up from 0% just four years ago.
“This major shift in harnessing the potential of psychedelics is being driven by research highlighting the effectiveness of psychedelic-based treatments.”
He also noted that psilocybin is of interest to investors. Psilocybin is a psychedelic prodrug compound found in more than 200 species of fungi and is currently in a Phase III program by Compass Pathways for treatment-resistant depression.
Smriti Joshi, chief psychologist at Wysa, explained the drug’s potential: And anxiety. For example, research on psilocybin, the active compound in magic mushrooms, shows that it can promote deep and lasting changes in mood and cognition. Recognizing its potential importance, the FDA granted Breakthrough Therapy designation to psilocybin-assisted therapy for treatment-resistant depression. Our understanding of the neurobiological and psychological mechanisms behind these effects is evolving, contributing to a more nuanced understanding of how psychedelic treatments can be incorporated into mental health care. Masu. ”
Investors are interested, but there are obstacles
Analysis by GlobalData found a 500% increase in partnership deals related to psychedelics between 2019 and 2023, with more than 40 partnerships established since 2019. Bradbury explained: Changes in public opinion and regulation have collectively created a favorable environment for psychedelics to be approved and used. ”
“Investment in psychedelic research and development is surging,” Belotsky said, “largely due to the high unmet need and increasing prevalence of mental health disorders post-pandemic.” I think there is.
He went on to explain that the promotion of regulatory frameworks and guidance by governing bodies has further increased investor confidence. “The industry is maturing and we expect larger institutional investors to come in as more FDA approvals are announced. has begun to enter this space with deals such as Citadel Advisor’s acquisition of 8.1% of Compass Pathways stock and Citadel Advisor’s acquisition of 4.9% of Compass Pathways stock.
However, the growing sector still faces obstacles, with schedule and public perception being two major hurdles. Changing regulations regarding psychedelic treatments in mental health are allowing the field to grow, but obtaining permission to use substances in research is a long process and negative connotations are often present on the packaging. It has become a part.
“Because substances such as psilocybin and MDMA have been used historically for recreational purposes, there may be both federal legal issues and social stigma associated with taking these substances for therapeutic purposes,” Dr. Bradbury said. “There is,” he explained.
Even if these obstacles are overcome, there are scalability issues. To be effective in the treatment of mental health, psychedelics need to be administered alongside psychotherapy, and their introduction requires investment in training staff and developing the necessary infrastructure.
Boretsky said. pharmaceutical technology “The use of psychedelic therapy will require significant education among physicians and internists about both administration and stigma. Companies and academic institutions have already begun offering training courses for certified therapists. , I cannot stress enough the need for a more positive discussion of psychedelic therapy in the medical community.”
