Issue 186

What’s next for MDMA therapy following FDA rejection?

On August 9 the U.S Food and Drug Administration rejected Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy. However, the journey to approval is not over yet, and Lykos is now working to address the issues that led to the rejection.

While the news is a devastating blow to the 13 million in the U.S. living with PTSD, it comes as no surprise as the decision follows the recommendation of an independent advisory committee not to approve the therapy in June.

Rejecting the NDA, the FDA issued a complete response letter (CRL) citing concerns over blinding, expectancy bias, and insufficient data to demonstrate durability. The authority has now requested a further Phase 3 trial which will take years and cost millions to complete.

Lykos Therapeutics (Formerly MAPS PBC) has requested a meeting with the FDA to discuss its resubmission.

Since the decision, three studies from Lykos have been retracted from the academic journal Psychopharmacology due to “protocol violations amounting to unethical conduct”, the organisation has laid off 75% of its staff, and Founder and President of MAPS Rick Doblin has stepped down from the board of directors.

Psychedelic Health explores what’s next for MDMA therapy.

THE FOUR FACTORS OF REJECTION

The Trip Report by Beckley Waves explores the issues in psychedelic trials that led to the rejection of MDMA therapy by the FDA.

“Four Factors of Rejection set the stage for the rejection of MDMA-Assisted Therapy.

– Methodological Limitations: How do you study a treatment you can’t blind for a condition you can’t measure?

– Industry (In)experience: Outsiders playing an insider’s game

– Ossified Institutions: An inadequate regulatory apparatus ill-equipped to assess novel therapeutic modalities

– Circular Firing Squad: Ideological differences within the “psychedelic community” led to an effective opposition campaign against Lykos”

US POLICYMAKERS SHOULD EMBRACE MDMA

In The Financial Times, Helene Servillon, founding partner of capital fund JourneyOne Ventures, says policymakers should embrace MDMA.

“We should continue to look backwards in order to move forwards. The current approach towards healthcare is not working. We are not well as a society and the cost is high. Mental illness costs the US economy $282bn a year, according to a study published this year by the National Bureau of Research.

“The US is in the grip of a mental health epidemic. Patients are ready to try alternatives…

“For now, the millions of Americans with PTSD and the patients who aren’t responsive to existing treatments have to bear the burden of waiting for new treatment to be approved.”

SCIENCE AND RESEARCH

LSD reshapes the brain’s response to pain, a new neuroimaging study has found.

Researchers have discovered how DMT alters the visual cortex to create psychedelic visuals.

Frontiers in Psychology has published a new editorial on Psychedelic Humanities.

Research centre aims to answer key questions on psychedelics in healthcare.

REGULATION AND LEGISLATION

What to know about Massachusetts’ psychedelics ballot question.

Colorado finalises business rules for psychedelics industry.

BUSINESS AND INVESTMENT

MindBio says microdosed psychedelic shows long-term benefit in depression.

Cybin announces plans for CYB003 Phase 3 programme in Major Depressive Disorder in the US.

Optimi Health completes export of MDMA to Australia for PTSD Treatment.

Optimi Health and Psyence Biomedical sign Letter of Intent to advance global psilocybin drug development.

ARTICLES OF INTEREST

The NHS should not keep increasing mental health awareness because it cannot cope with current levels of demand, one of its board members has said.

The Irish Times reports that global research warns of accelerating mental health problems and illness among young people.