Issue 136

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drug

The U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.

This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.

There has been growing interest in the therapeutic potential of psychedelic drugs in recent years. They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions. However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges that require careful consideration.

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MHRA APPROVES PSILOCIN TRIAL FOR MAJOR DEPRESSIVE DISORDER

Recent studies have estimated the cost of mental health problems to the UK economy at over £110bn a year.

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61% OF AMERICANS SUPPORT LEGALISATION OF PSYCHEDELIC THERAPY

More than 6 out of 10 American voters support legalising regulated therapeutic access to psychedelics.

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BUSINESS AND INVESTMENT

Cybin reports 2023 fiscal results. The company had C$16.6 million cash as of 31 March 2023.

PSYCH Symposium: the future of psychedelic medicine in the EU. MEPs will discuss the future of psychedelic healthcare at the landmark event.

From promise to practice: A dose of reality for psychedelic therapies. The the importance of protecting patients.

Bright Minds announces proposed share consolidation. The company hopes to regain Nasdaq compliance.

Psychedelic-assisted therapy in Australia. Psilocybin and MDMA treatments will be legal to prescribe from 1 July.

Business leaders are using psychedelic medicines to boost creativity and focus. Psychedelic substances are being used to enhance cognitive function

An overview of 2C-B. 2C-B is a novel tryptamine first synthesised by Alexander Shulgin.

Cybin appoints Sanford R. Climan as a Strategic Advisor. Climan was formerly President of Worldwide Business Development of Universal Studios.

SCIENCE AND RESEARCH

Psychedelic medicines promote plasticity by binding to BDNF receptor TrkB. LSD  and psilocin directly bind to TrkB with affinities 1,000 times higher than other antidepressants.

The use of psychedelics rises in the United States. Young adults nearly doubled their consumption of psilocybin-producing mushrooms from 2018 to 2021.

Want to find out exactly what is driving this exponential new wave of interest into the psychedelic space? 

Following on from the ranging discussions in Denver last week, PSYCH Symposium: London 2023 returns next Thursday. We have released a very limited number of 3 FOR 2 group tickets to attend – saving over £400.

TICKET REGISTRATION

REGULATION AND LEGISLATION

UN experts and global leaders call for drug decriminalisation. The International Day Against Drug Abuse and Illicit Trafficking was marked by a push for regulatory reform.

The history of psychedelic medicine and criminalisation. Psychedelic substances have been used around the world for thousands of years.

California Assembly Committee approves bill to legalise psychedelic medicine. The legislation was introduced by Senator Scott Wiener.

Colorado governer calls for expungement of convictions related to psychedelic medicine. He has called on lawmakers to enable him to issue mass pardons.

ARTICLES OF INTEREST

Child mental health referrals in the UK surpass a million. Almost one and a half million children were referred to mental health services in 2022.

Half a million Canadians unable to work due to poor mental health. Nearly 40 per cent have taken time off work in the last five years because of their mental health.

Study analyses the relationship between money and mental health. The review highlights the impact of financial circumstances on mental wellbeing.

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