The U.S. Food and Drug Administration has accepted a new drug application from Lykos Therapeutics, previously known as MAPS Public Benefit Corporation, for the use of MDMA-assisted therapy in treating post-traumatic stress disorder.
The acceptance finally kicks off an anticipated review process, with the FDA granting the application priority status and setting a target action date of August 11, 2024. If approved, the therapy would be the first of its kind to receive federal approval, potentially offering a new treatment option for individuals with severe mental afflictions.
“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” Lykos CEO Amy Emerson said in a statement.
Lykos’ application for MDMA-assisted therapy, which combines the use of MDMA with psychotherapy, is based on the results of two Phase 3 clinical trials. Those trials reported that the treatment was effective and safe for patients with severe PTSD, with no serious adverse events recorded among participants receiving MDMA.
The FDA assigns priority review to applications for therapies that have the potential to provide significant improvements in the treatment of serious conditions, according to a news release.
The acceptance of Lykos’ application firmly signals what could be a watershed year when it comes to wider acceptance psychedelic treatments in mental health care, particularly for conditions like PTSD which impact millions and can be challenging to manage with existing therapies.
“We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved,” Emerson said.
The timing is ideal, as Lykos last month closed on $100 million worth of Series A funding to round out its rebranding.
The nonprofit research organization that originally started the public benefit arm Lykos branched from said it could be the first of many similar treatments to get approved, “backed by decades of research incubated by MAPS,” founder and president Rick Doblin said in a statement.
Doblin added, “Thirty-eight years ago, one of my primary motivations for founding MAPS was to carve a path for psychedelic-assisted therapies to become FDA-approved treatments… we are celebrating the therapists and subjects who participated in the Phase 2 and Phase 3 studies and the team at Lykos Therapeutics on the historic accomplishment they have achieved.”