The company plans to request a meeting with the FDA to discuss the decision and explore the agency's recommendations for resubmission. The treatment, intended to be administered alongside talk therapy by a licensed mental health provider, had shown promise in Lykos' two late-stage trials involving over 190 patients. Participants either received MDMA doses in addition to therapy or a placebo, with most showing a significant reduction in PTSD scores compared to the placebo group.
PTSD, a condition triggered by extremely stressful events, affects approximately 13 million Americans, including war veterans and civilians who have experienced natural disasters, abuse, or other traumas. Researchers continue to investigate the potential of psychoactive substances, including cannabis, LSD, and magic mushrooms, to treat various mental and behavioural health conditions such as PTSD, anxiety, and depression.
The Institute for Clinical and Economic Review, a nonprofit that evaluates clinical trials and drug prices, had previously reported insufficient evidence to support the benefits of MDMA-assisted PTSD treatment. The FDA's decision, conveyed through a "complete response letter" to Lykos, represents a considerable blow to the company and the broader movement to integrate psychedelics into mainstream mental health care. The treatment had garnered substantial support from patients, mental health professionals, and politicians from both parties. Advocates had launched a major public pressure campaign, emphasising the urgent need for new and effective treatments for veterans and others affected by PTSD. The FDA's decision is seen as a pivotal moment for the psychedelics industry, with potential implications for other drugs in the pipeline, such as psilocybin and LSD.
The FDA's advisory committee had previously voted against the evidence supporting the treatment, raising concerns about the clinical research's quality. The FDA echoed these issues in its decision, stating that the data limitations prevented the agency from concluding the drug's safety and efficacy for the proposed indication. Despite the setback, Lykos remains committed to advancing the research. Emerson reiterated the company's dedication to finding a path forward for patients, leveraging all available regulatory pathways.
The debate over Lykos' application has been divisive, with allegations of misconduct and bias in the clinical trials. Given the requirements for another trial, some experts believe psilocybin may now be poised to gain approval ahead of MDMA.
