A panel of advisers to the Food and Drug Administration cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.
However, strong supporters of MDMA therapy continue to praise its effectiveness, including advocate Lori Tipton who took part in the drug's clinical trials.
Doctors diagnosed the New Orleans resident with post-traumatic stress disorder after Hurricane Katrina hit her hometown.
"My brother passed away from an overdose. And then after that, my mother took the lives of two women and then took the life of herself. And I was the person who discovered their bodies within the house," Tipton said. "I had crazy mood swings, panic attacks, insomnia. I had intrusive thoughts, suicidal ideation."
Various forms of therapy didn't help. In 2018, she enrolled in a clinical trial to test the psychedelic drug MDMA, which is also known as ecstasy or molly.
Tipton underwent three supervised sessions where she was given microdoses followed by patient-guided talk therapy. She says reconnecting with buried memories opened an avenue for self healing.
"It allowed me to see that from a very different perspective, and to understand, like the amount of shame that I was holding on to and fear," Tipton said.
For now, the panel is not recommending MDMA move into the medical mainstream and felt the risks didn't outweigh the benefits.
"The only way to obtain this treatment legally in this country at this time is through clinical trials," Lalim Health founder Dr. April Soto said.
Dr. Soto says mind-altering medications can help patients come to terms with their trauma.
Lykos Therapeutics, the company sponsoring the study, presented two late-stage study results.
"67% of patients who had the MDMA no longer met criteria for PTSD," Dr. Soto said, compared to 32% of patients on the placebo.
She emphasizes the need for a meticulous medical evaluation due to the known safety risks that include hypertension, elevated blood pressure and tachycardia.
After six years, Tipton has not needed more MDMA therapy and remains an advocate.
"Unbelievable, the amount of lives that can save, unbelievable, you know, that's my experience with it at least," Tipton said.
MDMA is the first in a series of psychedelics - including LSD and psilocybin - that are expected to come before the FDA for review in the next few years as part of a resurgence of interest into the drugs' medical potential, which advocates claim could transform the treatment of mental health disorders.
The FDA usually follows the panel's recommendation, but they're not required to. Their final decision is expected Aug. 11.
The Associated Press contributed to this report.