The panels vote signals a setback for Lykos and reflects the challenges in regulating psychedelics for mental health treatment.
Each day we postpone this therapy, I ask, At what cost?
How many more people need to die before we approve an effective therapy?
Photo Illustration by Michela Buttignol for Verywell Health; Getty Images
While the vote on Tuesday is non-binding, the FDA often follows its advisory panels recommendations.
The agency is expected to make a final decision on whether to approve the treatment in mid-August.
The FDA panel considered data from two phase 3 clinical trials submitted by Lykos.
Participants had three treatment sessions that were eight or more hours long.
They took two doses of MDMA a couple of hours apart under the guidance of a certified therapist.
They then had nine follow-up sessions to help describe the experiences of medication sessions and work through the trauma.
Its hard to design a double-blinded trial in which participants do not notice the mind-altering effects of psychedelics.
That could skew how the therapists interacted with their patients.
About 40% of people in each trial had taken MDMA before.
Plus, only about 5% dropped out from the MDMA groups in both trials.
Lykos collected long-term follow-up data.
Other groups, like the American Psychiatric Association, urged regulators to closely monitor patients and drug dispensing.
Companies that are running current and future clinical trials may have a better roadmap to follow.
Weve been learning as we go, Farchione said.
Additionally, the clinical trials included mostly White participants.
Some panelists noted that the safety and efficacy could differ in non-White groups.
The quality of the psychotherapy is perhaps the most important part of MDMA-assisted therapy.
But the FDA doesnt oversee the therapists themselvesthats largely the job of state licensing boards and other groups.
Acitizen petition to the FDAasked that the public comment period be extended, citing various safety concerns.
There have been no studies specifically comparing how the guidance in the manual compares to other kinds of psychotherapy.
Lykos is the first company to put a psychedelic-assisted therapy candidate up for review by the FDA.
Despite the unfavorable outcomes, the FDA meeting provided learning lessons for other companies in the psychedelics-assisted therapy space.
The FDA will make a final decision on whether to approve MDMA as a treatment for PTSD in August.
Department of Veterans Affairs.PTSD: National Center for PTSD.
2021:27;10251033. doi:10.1038/s41591-021-01336-3
Multidisciplinary Association for Psychedelic Studies.Treatment manual: MDMA-assisted therapy for PTSD.
