Psychedelic-Assisted Therapy for PTSD:
On the Verge of FDA Approval

Lykos Therapeutics (formerly MAPS PBC) ("Lykos") announced that the U.S. FDA has accepted its new drug application for MDMA used in combination with psychological intervention, including psychotherapy for individuals with post-traumatic stress disorder (PTSD). The FDA has granted the application priority review, with a decision expected by mid-August 2024. The FDA gives priority review to drugs that could significantly improve treatment of serious conditions compared to existing options.

The application for FDA approval was supported by results from several studies, notably two significant Phase 3 trials. These studies tested the effectiveness and safety of MDMA therapy versus placebo in treating severe PTSD, achieving their main goals. The findings were published in the prestigious journal, Nature Medicine.

Innovation in mental health has stagnated for decades. In the past three years, Europe has approved only 1 new psychiatric treatment, compared to 68 in oncology. While the U.S. is on the brink of approving the first psychedelic-assisted therapy, Europe significantly lags behind. This is primarily because the current incentives and rewards for companies to conduct large-scale pivotal trials on psychedelics are insufficient in Europe, highlighting the need for enhanced support and incentives to advance novel mental health treatments.

About PTSD
PTSD is a serious mental health condition that can develop when a person experiences or witnesses a traumatic event. PTSD affects 8 million Europeans each year with women and disadvantaged or marginalized groups more likely to be affected. While often affecting the military personnel, the largest cause of PTSD is non-combat-related trauma such as sexual violence, unexpected death of a loved one, life-threatening traumatic event or interpersonal violence. PTSD results in debilitating symptoms including nightmares and intrusive thoughts related to the trauma, mental and/or physical distress in response to trauma-related stimuli, avoidant behaviours, negative thoughts and feelings, and hyperarousal.  These symptoms can impact nearly all aspects of a person's life. People with PTSD frequently also experience anxiety, depression, substance use disorder and suicidal ideation.  They also may have a greater incidence of medical conditions that impact their physical health, including heart disease, metabolic syndrome and asthma. 

Discover full details in the Lykos official press release here.