Food and Drug Administration (FDA) has rejected MDMA Also known as ecstasy, it is used as a treatment for post-traumatic stress disorder (PTSD).PTSD), drug maker Lycos Therapeutics said in a news release. MDMA is an entactogen, a class of psychoactive drugs that produce experiences of emotional communication, bonding and emotional openness.

According to a CNN report, this is the first time the FDA has considered a psychedelic drug for medical use. This new treatment has the potential to transform a field with critical needs, but the review process has also raised questions about how it should be used in a clinical setting. MDMA is currently classified as a Schedule I drug under the Controlled Substances Act, or a restricted substance that has “no currently accepted medical use and a high potential for abuse.” Reclassifying the drug to a lower level would be a significant change involving multiple federal agencies.

Lycos Therapeutics had asked the FDA to approve the drug as part of a treatment that is given alongside talk therapy. The FDA’s decision came after an independent advisory committee declined to approve the drug in June, saying there was not enough evidence that the therapy was safe and effective.

The FDA said there were numerous problems with it, including poorly designed studies, allegations of sexual misconduct during mid-stage clinical trials and the potential for serious health risks after taking the drug, including cardiovascular problems and abuse. According to a report by NBC News, a review by FDA scientists published before the June meeting also raised concerns about how the trials were conducted, including that many patients and physicians were possibly able to guess who was given the drug and who was given a placebo.

“I think this will be a temporary setback,” said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania. “The advisory committee and the FDA have given very clear signals about what they want in terms of study design and adverse event reporting, so Lycos and other companies should have a clear idea of ​​how to proceed if they want to get psychedelics approved.”

The FDA has also asked the company to complete a Phase 3 clinical trial to further study the drug’s safety and efficacy. Lykos said the agency has raised concerns similar to those raised during an advisory committee meeting in June. The drugmaker said it plans to ask the FDA to reconsider the decision.

“The FDA’s request for another study is extremely disappointing, not only for all who dedicated their lives to this pioneering effort, but primarily for the millions of Americans suffering from PTSD and their loved ones who have seen no new treatment options for over two decades,” Lycos CEO Amy Emerson said in a press release.

In a statement, an FDA spokesperson said the agency believes there is a “great need” for additional treatment options for PTSD. Still, “as discussed in the advisory committee meeting, the data contained in the application have significant limitations that prevent the agency from concluding that this drug is safe and effective for the proposed indication,” the spokesperson said.

Get the latest news on Times Now as well as breaking news and top headlines from across health and the world.