The U.S. Food and Drug Administration (FDA) recently rejected an application to approve the use of MDMA as a treatment for post-traumatic stress disorder (PTSD). The MDMA formulation, developed by Lykos Therapeutics, would have been administered in combination with psychotherapy if it had been approved.
In its rejection, the federal agency requested for more clinical trials to be done to gather additional data on the drug’s effectiveness and safety. This decision comes just months after the FDA’s advisory committee determined that the application made by Lykos was lacking on both fronts.
The decision is a significant change in the drug’s trajectory, seeing as in 2017, the FDA approved the psychedelic’s review process. This was driven by promising findings in the early stages which suggested that MDMA, when administered together with psychotherapy, could provide relief to the millions with post-traumatic stress disorder.
During this period, Lykos applied for approval to market its psychedelic formulation, called midomafetamine. In its application, the company included strong data from a pair of phase 3 trials that demonstrated decreased scores for symptoms of PTSD.
The FDA declined, however, and requested a second trial, which needs to include improved policies following misconduct involving therapists who abused a patient. The panel, made up of 11 members, voted on the matter, with 9 agreeing that the evidence provided didn’t demonstrate the effectiveness of the drug. Additionally, 10 of them ruled that the drug’s potential benefits didn’t outweigh the risks.
The company’s chief executive, Amy Emerson, revealed that carrying out another trial would take a couple of years.
Soon after the rejection, editors at the “Psychopharmacology” journal retracted three papers from scientists associated with MAPS Public Benefit Corp. A pair of the papers analyzed half a dozen clinical trials that were included in the submission made to the FDA. In their report, the editors highlighted violations in protocol that amounted to unethical conduct.
Additionally, Lykos announced that Rick Doblin would be stepping down from the company’s board to allow him to freely advocate for psychedelic treatments. Doblin pioneered the MDMA treatment. Lykos also announced that it would be letting go 75% of its workforce.
Despite this setback, scientists could learn a lot from Lykos and its journey of studying treatments for conditions such as addiction and depression. University of California’s David Olson notes that it is possible to develop psychiatric medications while avoiding psychotherapy completely during trials.
He explained that if a drug was effective and safe, there is no reason a physician couldn’t prescribe the drug with psychotherapy because the FDA didn’t regulate medicine as a practice.
Many startups in the psychedelics space, such as Mind Medicine Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), will be reflecting deeply about what has happened to the MDMA application submitted by Lykos Therapeutics. Any lessons they can learn will be invaluable because implementing the needed changes can make or break years of work invested in developing a psychedelic drug candidate.
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