On August 9, the FDA rejected Lykos Therapeutics' proposal to legalize MDMA-assisted therapy, delivering a significant setback to the psychedelic movement that rippled through the industry and beyond. Although the FDA didn't rule out the potential for legal MDMA in the future, it issued a Complete Response Letter (CRL) to Lykos, requesting an additional Phase 3 study to confirm the treatment's safety and effectiveness for PTSD before resubmitting the application. This requirement poses a considerable challenge for Lykos, likely necessitating several more years and substantial fundraising to accomplish.
This outcome was unexpected for the mainstream psychedelic field, especially given the FDA's previous alignment with the research. It appears to result from several factors: the FDA's emphasis on biomedical reductionism, a lack of understanding regarding the role of therapy with MDMA, challenges with blinding in psychedelic research, concerns about sexual abuse, and a wave of misinformation from mainstream media questioning the research's integrity. Additionally, longstanding social taboos and prejudices surrounding psychedelics, rooted in religious, moral, and cultural beliefs, contribute to a complex political situation that is difficult to navigate.
In response to the news, Lykos announced a major restructuring, cutting 75 percent of its workforce and retaining only a small core team. Rick Doblin, the charismatic yet sometimes controversial founder of MAPS—the non-profit that gave rise to Lykos—also stepped down from the company’s board. "After more than 38 years of work, I am deeply disheartened by the FDA’s decision on this urgently needed therapy, but I am encouraged that Lykos will continue clinical research to address the FDA’s concerns," Doblin said in the announcement. "By resigning from the Lykos Board, I can more freely advocate as a public supporter."
One of the most significant moves Lykos has made in response to the recent setback is appointing David Hough, a former Johnson & Johnson executive, to lead the company’s ongoing clinical development program and manage its interactions with the FDA. Hough previously served as Vice President of Research and Development at J&J Innovative Medicine, where he held leadership roles for 17 years. He was instrumental in bringing Spravato, Johnson & Johnson's patented esketamine nasal spray, to market. A West Point graduate, Hough also served as an Army officer and psychiatrist for a decade across various military hospitals.
Johnson & Johnson, a major pharmaceutical company, played a significant role in the opioid crisis and faced lawsuits for its involvement in fueling the epidemic. From the 1990s through at least 2016, the company and its subsidiaries were engaged in cultivating and processing opium poppy plants used to produce opioid drugs such as oxycodone, hydrocodone, fentanyl, naloxone, and others. By 2015, Johnson & Johnson had become the leading U.S. supplier of pharmaceutical ingredients for opioid drugs, selling these active components to other major opioid manufacturers.
Johnson & Johnson, along with three major drug wholesalers—AmerisourceBergen, Cardinal Health, and McKesson—has faced thousands of civil lawsuits from local and state governments, as well as Native American tribes across the U.S. These lawsuits alleged that the companies' business practices played a significant role in the opioid crisis. Collectively, the four companies have paid $26 billion to settle these claims.
“Johnson & Johnson’s aggressive marketing of opioids systematically overstated the effectiveness of the drugs for treating pain long term and understated the risk of addiction,” said a statement released by the office of Washington State Attorney General Bob Ferguson, which reached a $149.5 million settlement with Johnson & Johnson in January this year. “Johnson & Johnson marketed its opioid drugs for chronic pain conditions like headaches, low back pain and fibromyalgia, despite evidence that opioids were not effective at treating these conditions.”
Although this decision may delay the integration of psychedelics into mainstream healthcare by years, the science and research conducted thus far will continue to have an impact. Ongoing research will further shape the field.