Lykos Therapeutics said that the U.S. Food and Drug Administration (FDA) has rejected its treatment based on the hallucinogenic molecule MDMA for PTSD sufferers, citing insufficient data to support approval.
For a long time, proponents of MDMA—also known as molly or ecstasy—believed that it might alleviate mental health issues and had therapeutic uses beyond its illegal usage.
The FDA’s choice to reject the therapy aligned with the vote cast by the agency’s expert committee, which was reviewing Lykos’ application. In the June panel meeting, FDA advisers raised issues regarding the manner in which the clinical trial was executed.
These concerns involved a notable absence of documentation on whether the trial participants had misused the drug, flaws in the trial’s design, and the need for additional evidence.
Lykos reported that the FDA has requested an additional late-stage trial to further examine the drug’s safety levels.
The company intends to ask for an appointment with the FDA to appeal the decision and talk more about the agency’s recommendations for resubmitting the application fto get the green light for the MDMA capsules.
“The FDA request for another study is deeply disappointing,” stated Lykos CEO Amy Emerson. “While conducting another phase 3 study would take several years, we still maintain that many of the requests tata, post-approvhat had been previously discussed with the FDA … can be addressed with existing dal requirements or through reference to the scientific literature.”
The treatment, a pill form of MDMA created by the public-benefit firm Lykos, was designed to be used together with talk therapy sessions led by a mental health professional.
Lykos conducted two late-stage trials with over 190 participants, who either received MDMA along with therapy or a placebo. The company reported that most participants who received MDMA demonstrated a significant reduction in PTSD scores compared to those given the placebo.
PTSD, a disease triggered by exceptionally stressful circumstances, impacts 13 million Americans and is usually associated with combat veterans. But natural disasters, violence or other stress may also induce disease in people.
Walter Dunn, an assistant professor in the psychiatry department of the University of California, Los Angeles, remarked that although the decision may be disheartening for some, the additional information and requirements requested by the FDA are for the purpose of enhancing their comprehension of the treatment.
Evercore ISI analyst Gavin Clark-Gartner mentioned before the decision that the regulator’s rejection of Lykos’ treatment might not negatively affect other companies in the psychedelic industry, as they have pursued drug development and trials using somewhat different methods.
Researchers have been exploring how psychoactive substances, whether sourced from cannabis, magic mushrooms or LSD, could potentially treat various mental and behavioral health disorders, including PTSD, depression and anxiety.
Earlier this month, a cohort of 80 lawmakers wrote to Biden and FDA Commissioner Robert Califf, pleading with them to give green light to the treatment, writing that they cannot turn a blind eye as their veterans continue suffering in silence.
