Issue 181

FDA MDMA therapy advice may be a setback, but it is not the end of the road

An advisory body to the U.S Food and Drug Administration (FDA) has recommended against the approval of Lykos Therapeutics’ MDMA-assisted therapy – but the development is not deterring the industry.

While the final decision on the matter is not expected until 11 August 2024, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has delivered a major blow to the development.

This advisory vote may not bode well, however, industry stakeholders believe this is not the end of the road for MDMA-assisted psychotherapy.

Rivki Stern Youdkevich, Co-founder and CEO at Shortwave Life Science, which is developing psychedelic medicines for the treatment of anorexia nervosa, has said the decision is not deterring their developments.

Youdkevich commented: “We were disappointed to learn of the panel’s recommendation but we are not discouraged. Mental ill health is growing at an alarming rate with an increasing number of conditions affecting more people in every age group worldwide. This necessitates novel approaches to medication and treatment, as existing therapies do not suffice. So our enthusiasm for development of psychedelics-based treatments and medicine remains undiminished.”

Adding to the developments, in the days following the FDA’s advice, a Dutch advisory committee, which conducted conduct a multidisciplinary analysis of the health risks of MDMA to advise the Dutch Cabinet, recommended the Government should allow access to MDMA-assisted therapy for people living with PTSD.

THERAPIST TRAINING PROGRAMMES NOT FIT FOR PURPOSE

Dr Sarah Bateup, Scientific Advisor at Clerkenwell Health, explores the need for science-based, evidence-led psychedelic-assisted therapy training (PAT).

“As we move towards a future where PAT becomes more mainstream in treating metal health disorders, we must ensure all training programmes robustly assess whether a trainee can consistently deliver high quality therapy…”

PSYCHEDELIC THERAPY FOR PTSD IN THE UKRAINE BRINGS HOPE

Psychedelic-assisted therapy is being increasingly discussed in Ukraine as a way of treating PTSD following the current mental health crisis.

With a view to global development, which has been inching towards supporting the medical use of psychedelics, Ukrainian institutions are supporting clinical studies for psychedelic-assisted therapy as an innovative way of treating PTSD.

SCIENCE AND RESEARCH

Research suggests that psychedelic drugs can reopen critical periods of brain development to create opportunities for re-learning and psychological healing.

Researchers will use neuroimaging to observe the effects of psilocybin on the human brain — in real-time.

A woman has found remarkable relief from her long-COVID symptoms through the use of MDMA and psilocybin, according to Science Alert.

Psychedelics may reduce death anxiety via panpsychism, a new study has suggested.

REGULATION AND LEGISLATION

An FDA advisory committee has advised that Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder is not effective.

New Jersey has shelved a plan to decriminalise psilocybin in favor of a bill only allowing its use for therapeutic purposes.

BUSINESS AND INVESTMENT

Insurance Business explores if psychedelics a huge insurance opportunity.

Optimi Health has secured an import permit from Mind Medicine Australia for MDMA and psilocybin capsules.

Psychedelic stocks tank after FDA advisors shoot down MDMA therapy for PTSD, reports Forbes.

The ASRI has unveiled the first bifunctional compound that acts as a 5-HT2A antagonist and a voltage-gated sodium channel blocker.

ARTICLES OF INTEREST

The Money and Mental Health Policy Institute, Martin Lewis’ charity, has issued five action points for the next UK Government to make insurance pricing fairer for those with mental health conditions.

The European Psychiatric Association, EUFAMI and GAMIAN-Europe, have launched a 2024 manifesto advocating for policies that prioritise the well-being of individuals and families affected by mental health conditions.