FOR IMMEDIATE RELEASE: February 9, 2024. The FDA has accepted a New Drug Application filed by Lykos Therapeutics for MDMA-assisted therapy, marking a significant step towards potentially using MDMA as a treatment for patients suffering from post-traumatic stress disorder (PTSD).
In recent years, there has been growing interest in the potential therapeutic benefits of MDMA, commonly known as ecstasy. Studies have shown that the drug can make people more social and less defensive, effects that some experts believe could be harnessed to treat loneliness in individuals with PTSD.
The acceptance of the New Drug Application by the FDA means that the agency will now review the safety and efficacy of MDMA-assisted therapy for PTSD. If approved, this would be a groundbreaking development in the field of mental health treatment.
The active ingredient in street drugs like ecstasy, MDMA, or midomafetamine, has been the subject of extensive research by organizations such as MAPS Public Benefit Corp. MAPS is seeking FDA approval to use MDMA in combination with therapy to treat PTSD, in what would be the first-ever FDA-approved treatment of its kind.
Several phase 2 trials have already indicated that MDMA-assisted therapy has an acceptable risk-Benefit profile in individuals with PTSD. These positive results have paved the way for a pivotal phase 3 study, known as MAPP1, which will further evaluate the effectiveness of MDMA in treating PTSD.
In addition to filing the New Drug Application, MAPS PBC has also announced a name change to Lykos Therapeutics. This rebranding reflects the organization's commitment to developing innovative therapies and highlights their focus on MDMA-assisted therapy for PTSD.
Advocates for MDMA-assisted therapy, such as Juliana Mercer, a 16-year Marine Corps veteran and current Director of Veteran Advocacy and Public Policy for Healing Breakthrough, emphasize the urgent need for alternative treatments for PTSD. Mercer believes that MDMA-assisted therapy has the potential to significantly improve the lives of veterans and others suffering from the debilitating effects of the disorder.
California lawmakers have also taken notice of the potential benefits of MDMA-assisted therapy. A bipartisan bill has been introduced in the state to allow individuals aged 21 and older to consume MDMA under medical supervision. This move reflects the growing recognition of MDMA's therapeutic potential and the need for further exploration in a controlled and regulated environment.
As the FDA reviews the New Drug Application for MDMA-assisted therapy, the medical community eagerly awaits the agency's decision. If approved, this groundbreaking treatment has the potential to transform the lives of countless individuals suffering from PTSD, offering them a new ray of hope in their journey towards healing.
