FDA Issues Complete Response Letter to Lykos Therapeutics for Midomafetamine Capsules in the Treatment of Post-Traumatic Stress Disorder

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The FDA has issued a Complete Response Letter (CRL) to Lykos Therapeutics regarding its New Drug Application (NDA) for midomafetamine capsules, intended to treat adults with post-traumatic stress disorder (PTSD). According to the company, the FDA stated that the current data are insufficient for approval, requesting an additional Phase III clinical trial that includes extensive measures to minimize bias. The decision comes amid concerns raised during an FDA Advisory Committee meeting, including issues related to the structure of the meeting.¹

"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Amy Emerson, CEO, Lykos Therapeutics, in a press release. "While conducting another Phase III study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature."

Breakthrough Therapy designation was granted to midomafetamine capsules in 2017, with Lykos negotiating a Special Protocol Assessment with the FDA. on a variety of bias minimization measures in the study design. Lykos stated that prior MDMA use was not previously viewed as detrimental, as 30% of participants in Lykos' Phase II studies reported prior use, which was shared with FDA before establishing the inclusion and exclusion criteria in the Phase III trial design. Additionally, the committee expressed concerns regarding psychotherapy, recommending further characterization of the extent to which psychotherapy contributes to treatment benefit and if it is even necessary.¹

"Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options. We intend to work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients who deserve access to midomafetamine-assisted therapy for PTSD,” stated Emerson, in the press release.

As a result of the CRL, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced plans to evaluate a path towards safe, legal access to MDMA-assisted therapy. As part of this strategy, MAPS intends to work on advancing research through incubating, informing, and inspiring research that enables new investigative directions, improves patient access and experience, and informs data-driven drug policy and education. Additionally, MAPS aims to work towards policy changes that advocates for public health, individual liberty, and equitable access, while continuing to shape culture based on evidence.²

MAPS and our supporters have been advocating for the development and supporting the FDA-approved research of MDMA-assisted therapy for more than 38 years; MAPS will continue working towards safe, legal access to this therapy for the more than 350 million people living with PTSD worldwide,” said Rick Doblin, PhD, founder, president, MAPS, in a press release. Our collective commitment to MDMA-assisted therapy remains unwavering. MAPS remains fully focused on supporting culturally appropriate research, rigorous science, and drug policy reform that empowers citizen advocacy in all areas of the world including those with high incidences of trauma and limited resources.”

Despite the setback, Lykos remains committed to advancing midomafetamine-assisted therapy, highlighting the urgent need for new PTSD treatments. The company plans to engage with the FDA to seek reconsideration of the decision and explore all available regulatory pathways to bring this therapy to patients.¹

References

1. Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD. Lykos Therapeutics. August 9, 2024. Accessed August 12, 2024. https://news.lykospbc.com/2024-08-09-Lykos-Therapeutics-Announces-Complete-Response-Letter-for-Midomafetamine-Capsules-for-PTSD

2. MAPS Statement on FDA Complete Response Letter on MDMA-Assisted Therapy for PTSD New Drug Application. MAPS. August 9, 2024. Accessed August 12, 2024. https://maps.org/2024/08/09/maps-statement-on-fda-complete-response-letter-on-mdma-assisted-therapy-for-ptsd-new-drug-application