Amy Emerson: The FDA Advisory Committee Meeting for Lykos' MDMA-Assisted Therapy

The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will meet on Tuesday, June 4, to review and vote on the clinical benefit of midomafetamine (MDMA)-assisted therapy in the treatment of patients with PTSD. The highly anticipated meeting precedes the PDUFA target date in mid-August this year for an FDA decision on Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted therapy for such patients—potentially setting a precendent for the regulation utility of psychedelics for the treatment of trauma and other psychiatric conditions.

Throughout the day-long PDAC meeting agenda will be a number of data and expert presentations, as well as items reserved for public and third-party discourse surrounding Lykos’ NDA. The third-party committee will additionally consider a risk mitigation strategy (REMS) proposal from the FDA to address potential ethical and safety concerns surrounding MDMA-assisted therapy.

In an interview with HCPLive headed into the meeting, Lykos chief executive officer Amy Emerson provided details and her company’s perspective headed into the anticipated meeting and committee vote.

HCPLive: What are the key topics that need to be discussed at the FDA meeting regarding MDMA-Assisted Therapy for PTSD?

Emerson: The panel will be discussing the safety and efficacy of MDMA-assisted therapy. A copy of their briefing book can be found here for more information.

HCPLive: What is the promising data on MDMA-Assisted Therapy for PTSD?

Emerson: Data from our MAPP2 clinical trial, a multi-site phase 3 study of MDMA-assisted therapy for post–traumatic stress disorder ("PTSD"), was published in the September issue of Nature Medicine. The MAPP2 study met its primary and secondary endpoints confirming the results seen in the first Phase 3 study (MAPP1) that were also published in Nature Medicine.

The treatment regimen studied took about 12 weeks and comprised of 3 treatment cycles.

• Each treatment cycle consists of 1 medication session and approximately 3 integration sessions.
• During the medication sessions a patient self-administers MDMA under the supervision of a qualified healthcare professional who provides psychotherapy and other supportive services.
• This is followed by a series of integration psychotherapy sessions to process the therapeutic gains.

More detailed information about the trial design and results can be found in the publications.

HCPLive: Are there specific safety concerns or potential for misuse that might be raised?

Emerson: Please see the FDA’s briefing document for information about their specific concerns.

HCPLive: What are the regulatory hurdles that MDMA-Assisted Therapy might face before approval?

Emerson: We are in discussions with the FDA around potential labeling and risk mitigation strategies (REMS) to support the responsible and careful introduction of investigational MDMA-assisted therapy, if approved, into the healthcare system.

HCPLive: How would the approval of MDMA-Assisted Therapy impact the field of psychiatry and the treatment of PTSD?

Emerson: PTSD poses a global mental health challenge, can be undiagnosed or misdiagnosed, and affects individuals for years.^1,2 Current treatments for PTSD can be effective for some, however they can also be associated with low adherence rates and early dropouts due to tolerability issues with re-exposure to trauma, tolerability of medication and/or insufficient response to treatment.^3,4,5,6

These challenges underscore the urgent need for new, evidence-based therapies and approaches to address this important public health issue. With no FDA approved PTSD treatment options in over 20 years,⁷ if approved this new modality may help to address this significant unmet need.

There are more than 13 million Americans who are affected by PTSD each year.⁸

We are focused on the integration of psychedelic-assisted therapies into the healthcare system if approved and we take our responsibility as leaders in this new category seriously. If FDA-approved, prescription MDMA will be launched with a careful consideration of its potential benefits and risks, in accordance with established medical guidelines, protocols and quality standards.

Because this is a new approach, we believe that training is critical for qualified healthcare providers interested in delivering MDMA-assisted therapy. We plan to offer robust training program on how investigational MDMA-assisted therapy was delivered in our Phase 3 program to support clinicians in achieving optimal real-world outcomes.

Our goal if we receive FDA approval is to scale responsibly to ensure availability of MDMA-assisted therapy to the mental health community more broadly over time. We hope that in pioneering this potential new modality, we are opening the door for future research and treatment options to be made available to patients in need.

References

1. ^{Qassem T., Aly-ElGabry D., Alzarouni A., Abdel-Aziz K., Arnone D. Psychiatric Co-Morbidities in Post-Traumatic Stress Disorder: Detailed Findings from the Adult Psychiatric Morbidity Survey in the English Population. Psychiatric Q. 2021;92(1):321–330. doi: 10.1007/s11126-020-09797-4. PMID: 32705407; PMCID: PMC7904722.}
2. ^{Gagnon-Sanschagrin P., et al. Identifying individuals with undiagnosed post-traumatic stress disorder in a large United States civilian population – a machine learning approach. BMC Psychiatry. 2022;22:630. https://doi.org/10.1186/s12888-022-04267-6.}
3. ^{Berger W., et al. Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2009;33(2):169–180. doi: 10.1016/j.pnpbp.2008.12.004.}
4. ^{Machado-Vieira R., et al. The Timing of Antidepressant Effects: A Comparison of Diverse Pharmacological and Somatic Treatments. Pharmaceuticals (Basel). 2010;3(1):19–41. doi: 10.3390/ph3010019.}
5. ^{Steenkamp MM., Litz BT., Hoge CW., Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015;314(5):489–500. doi: 10.1001/jama.2015.8370.}
6. ^{Lewis C., Roberts NP., Gibson S., Bisson JI. Dropout from psychological therapies for post-traumatic stress disorder (PTSD) in adults: systematic review and meta-analysis. Eur J Psychotraumatol. 2020;11(1):1709709. doi: 10.1080/20008198.2019.1709709. PMID: 32284816; PMCID: PMC7144189.}
7. ^{Stein MB., Rothbaum BO. 175 Years of Progress in PTSD Therapeutics: Learning From the Past. Am J Psychiatry. 2018;175(6):508-516. doi: 10.1176/appi.ajp.2017.17080955. PMID: 29869547}
8. ^{U.S. Department of Veterans Affairs. PTSD: National Center for PTSD. Accessed February 19, 2024. https://www.ptsd.va.gov/understand/common/common_adults.asp.}