Lykos Therapeutics, formerly MAPS Public Benefit Corporation, has announced it has received FDA acceptance and priority review for a New Drug Application (NDA) concerning its MDMA-assisted therapy for PTSD.
The FDA has accepted Lykos’s NDA for MDMA capsules used in combination with psychological intervention. This intervention includes psychotherapy and other supportive services provided by a qualified healthcare provider for individuals with PTSD.
Lykos has stated that the FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. Current statistics show that 89% of applications that meet their PDUFA deadline are approved. If this application is approved, it would make this the first MDMA-assisted therapy and psychedelic-assisted therapy.
In a press statement, Amy Emerson, chief executive officer of Lykos Therapeutics, commented: “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.
“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.”
The NDA submission was supported by results from several studies on the therapy, including two Phase 3 studies that looked at the efficacy and safety of the therapy. Both of these studies met their primary endpoints, which were a change in PTSD symptom severity and an improvement in functional impairment associated with PTSD.
While no serious adverse events were reported in the MDMA group in either study, Lykos highlights that the safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
The news has been welcomed across the pond by European campaign groups advocating for access to psychedelic-assisted therapy.
In a press statement, campaign group PAREA commented: “Innovation in mental health has stagnated for decades. In the past three years, Europe has approved only one 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.”
While the US makes strides in advancing psychedelic healthcare, Europe is now beginning to take note of this scientific development, with the European Medicines Agency (EMA) set to hold a multi-stakeholder workshop on medical psychedelics in April 2024.
The workshop aims to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.
The continent also made a recent historic advancement in the field of psychedelic research. In January 2024, the European Union announced €6.5 million in funding for research into psychedelic therapy as part of its Horizon Europe programme.
The funding has been awarded to a consortium of 19 partners from nine different European countries for a clinical trial – the PsyPal trial – which will study psilocybin-assisted psychotherapy for psychological and existential distress in people who are diagnosed with either chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) or atypical Parkinson’s disease (APD).
