Lykos Faces Significant Setbacks as FDA Rejects MDMA Therapy and Three Studies Are Retracted Due to Unethical Conduct

FDA Rejection:

The FDA has rejected Lykos Therapeutics' application for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), citing concerns over absent data and flaws in study design.

Staff Layoffs:

Following the FDA rejection, Lykos has laid off approximately 75% of its staff.

Study Retractions:

Three articles related to Lykos' MDMA treatment have been retracted by the journal Psychopharmacology due to unethical conduct at a research site.

Unethical Conduct:

The unethical conduct involved a therapist engaging in a sexual relationship with a study participant, which was not disclosed to the journal.

Company Response:

Lykos has expressed disagreement with the retractions, arguing that the issues should have been resolved through corrections rather than retractions and has filed a complaint with the Committee on Publication Ethics.

Impact on Psychedelic Research:

The retractions and FDA rejection highlight the need for high-quality data and ethical integrity in psychedelic research to maintain public trust and advance the field.