Safety concerns moved to the front late in the Food and Drug Administration's Sept. 14 public hearing on psychedelic medicines, as speakers raised known cardiac risks, the need for health screening before treatment, and sexual misconduct by providers, Fierce Biotech reported. One speaker, Susan Taymor Sagy, co-founder of the nonprofit Coalition for Psychedelic Safety and Education, told regulators that her 21-year-old, Shira, died following psychedelic use. Fierce did not report the cause or circumstances of the death, and MedicalDaily has not independently confirmed them.
The timing matters because the field may be nearing a decision point. Fierce Biotech described the FDA as moving toward a likely first approval of a psychedelic medicine, an assessment from industry reporting rather than an agency announcement. Compass Pathways is in the process of submitting a rolling application for its synthetic psilocybin drug. On the day of the hearing, Definium Therapeutics announced a third positive phase 3 result for its LSD tablet and said it has an FDA meeting set for the fourth quarter to discuss an application, according to Fierce Biotech's trial report.
