The FDAs decision comes two months after an advisory panelvoted overwhelmingly against approving the use of MDMA-assisted therapy.
Two phase 3 clinical trials provided compelling evidence that treatment was effective at resolving PTSD symptoms for many participants.
However, the panelists voiced concerns about patient safety and data integrity.
Illustration by Zoe Hansen for Verywell Health
The company said it would ask the FDA to reconsider that decision.
The decision is a setback for some psychedelics researchers and advocates for people with PTSD, including veterans groups.
After researchers started testing MDMA in humans, they found promising results.
That same year, the FDA designated MDMA as a breakthrough therapy and signed off on Lykos study design.
In two randomized control clinical trials, participants had three treatment sessions, spaced at least weeks apart.
The FDA advisory panel voted 9-2 against recommending the approval of the therapy.
A retracted study is considered to be untrustworthy and is removed from the scientific literature.
The misconduct in question was a focal point of the FDA advisory meeting.
The FDA advisors raised concerns that the dataset may not reflect the true outcomes of trial participants.
In the 1960s, psychiatrists in the U.S. began to study how the drug can improve therapy outcomes.
The potential of MDMA-assisted therapy to help veterans heal from post-traumatic stress disorder (PTSD) remains paramount.
Psychedelics researchers say that MDMA may benefit several mental health conditions.
The psychedelics research movement extends beyond MDMA.
Two companies are conducting phase 3 trials to test psilocybin in people with treatment-resistant depression.
Lykos and MAPS were first-movers.
They were an organization, then a company, that were moving first through this door.
There is a wave of other companies that will follow in Lykos footsteps, Gorman said.
CBC.Drug policy group condemns psychedelic research association for response to B.C.
2016;48(2):67-75. doi:10.1080/02791072.2015.1128580
