United States: The U.S. Food and Drug Administration and health authorities decided that they’ll not going to approve the medicine MDMA which is also known as Ecstasy or molly which basically works for treating post-traumatic stress disorder (PTSD).
As reported by Health-Day, MDMA is a drug that some people believe can help with mental health conditions, but the FDA said there isn’t enough evidence to prove it works for PTSD. This means the drug, which is currently illegal and cannot be used as a treatment for PTSD.
FDA Requests Further Clinical Trials
However, the FDA asked that Lykos conduct another clinical trial to determine whether MDMA is safe and really very effective against PTSD and a demand that could mean many years and millions of dollars before another chance at the approval would rise.
“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, who have not seen any new treatment options in over two decades,” Lykos Therapeutics CEO Amy Emerson said in a statement.
Although while conducting another phase 3 study would take several years and we still maintain that many of the requests that had been previously discussed with the FDA and raised at the advisory committee meeting that can be addressed with the existing data and the post-approval requirements or through reference to the scientific literature,” Emerson added.
Impact of the Decision
Many of them had assumed that FDA approval was assured and given that the Lykos’s trials had been designed in the consultation with the agency.
The company trial involved 100 people who had been diagnosed with PTSD for an average of almost 15 years.
However, this particular discussion was actually not total surprise and FDA advisory board that met in June decided against recommending MDMA as a treatment.
If it had been already approved the drug and would have been the first psychedelic drug regulated by the some of the federal authorities.
“This is an earthquake for those in the field who thought FDA approval would be a cinch,” Michael Pollan, co-founder of the UC Berkeley Center for the Science of Psychedelics, told the New York Times. He’s also the author of the best-selling “How to Change Your Mind,” a book that’s helped alter public attitudes towards psychedelics in general.
So hereby there are almost 86 percent of the participants who received MDMA which is already combined with psychotherapy saw the symptoms subside and 71 percent are no longer met the criteria for PTSD by the study’s end and that’s compared to 48 percent who took a placebo alongside their talk therapy.