For the first time ever this week, a panel from the United States Food and Drug Administration considered approving a psychedelic drug for medical use. Unfortunately for biotech investors, veterans, advocates and others, the panel overwhelmingly shot down the proposal.
The FDA board voted 10-1 to reject permitting the use of MDMA as a treatment for post-traumatic stress disorder. For their decision they cited an unacceptable level of risk, inadequate clinical trials conducted by Lykos Therapeutics (formerly MAPS Public Benefit Corporation) and insufficient data. Following the reccomendation, the FDA will make a final decision later this year.
Lykos, responsible for top-tier research on the substance, raised over US$100 million to help support regulation of the drug in January. But, despite a lack of monetary concerns, it looks like it may be time for the mental health advocacy organization to head back to the drawing board this summer. The MAPS company submitted a new drug application to the FDA in December, which Lykos said was a filing resulting from 30 years of clinical research, but the battle for regulated access in the U.S. continues.
“It seems like there are so many problems with the data,” Melissa Barone, panel member and psychiatry professor from the University of Maryland, said. “Each one alone might be okay, but when you pile them on top of each other, there’s just a lot of questions I would still have about how effective the treatment is.”
Shares of psychoactive drug developers like Mind Medicine (MindMed) Inc (Nasdaq: MNMD), COMPASS Pathways plc (Nasdaq: CMPS) and Cybin Inc (NYSEAMERICAN: CYBN) dropped significantly following the news.
MDMA treatment for PTSD and other mental illnesses has a big drawback — a single treatment is effective. That means small profit potential compared to lifetime treatment with conventional pharmaceuticals. Maybe that’s why an FDA advisory committee shot it down. One of the…
— Robert F. Kennedy Jr (@RobertKennedyJr) June 5, 2024
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FDA’s final decision expected in August
Fortunately for millions of Americans suffering from PTSD, the recent rejection is not the FDA’s final decision on the matter. A conclusive determination will be made by the agency later this summer.
The advisory panel’s vote serves a recommendation, but the FDA has been known not to follow its advice on certain matters in the past. In fact, it does the opposite about 33 per cent of the time.
It should be noted that the government organization designated the drug as a breakthrough therapy in 2017 and has publicly acknowledged MDMA’s therapeutic potential.
“I hope that the drug gets approved but in a way where it can be made available and monitored in a responsible manner,” Dr. Rachel Yehuda, Director of the Center for Psychedelic Psychotherapy and Trauma Research at Mount Sinai’s Icahn School of Medicine, told CNN.
rowan@mugglehead.com
Triptherapie
January 24, 2025 at 7:36 am
The photo you used are crystals of a legal MDMA analog we’re using in the Netherlands to comply with the current law.