In a decision that has disappointed many, the U.S. Food and Drug Administration (FDA) announced on Friday that it has rejected MDMA as a treatment for post-traumatic stress disorder (PTSD). The FDA stated that "significant limitations" in the data prevent them from concluding that the drug is safe and effective for this proposed indication.

MDMA, commonly known as ecstasy or molly, is a psychedelic drug with effects similar to methamphetamine, according to the National Institute on Drug Abuse. Veteran organizations have long been advocating for psychedelic-assisted therapies as a potential solution for treating mental health challenges, including PTSD.

The FDA's rejection comes close to two months after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD. The agency has now requested another Phase 3 trial to confirm the drug's safety and efficacy. Lykos Therapeutics, the California-based company that filed the drug application, intends to meet with the FDA to appeal the decision.

Amy Emerson, the CEO of Lykos Therapeutics, expressed disappointment in the FDA's request for another study, stating, "The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones."

However, an FDA spokesperson defended the decision, stating that there are significant limitations to the data provided in the application, preventing the agency from confirming the drug's safety and effectiveness for the proposed indication. The agency emphasized the need for further research and development in order to explore innovative treatments for PTSD and other mental health conditions.

PharmAla Biotech, a Toronto-based company focusing on researching and developing MDMA derivatives, responded to the decision, acknowledging the FDA's responsibility but also highlighting the crucial need for novel treatments for PTSD. The CEO, Nicholas Kadysh, stated, "MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient treatments in two jurisdictions, Canada and Australia, entirely supplied by PharmAla."

Another CEO, Joe Perekupka of Freespira, a Washington-based company specializing in FDA-approved digital therapeutics for PTSD and anxiety, expressed support for the FDA's commitment to patient safety and the need for additional effective treatments. Perekupka stated, "We believe in the importance of diverse treatment options and will continue to focus on our mission of democratizing access to advanced mental health care."

As the debate surrounding the use of MDMA for PTSD treatment continues, both pharmaceutical companies and mental health advocates are committed to ongoing research and development to demonstrate the safety and efficacy of these alternative therapies. With millions of Americans affected by PTSD, the search for new treatment options remains a pressing need.

Fox News Digital reached out to the FDA and Lykos Therapeutics for further comment on the decision, but no response has been received yet.