Lykos Offers New Measures for Additional Oversight if MDMA-AT Is Approved
On August 1, Lykos Therapeutics announced a series of new initiatives and measures to provide additional oversight for its proposed MDMA-assisted therapy (MDMA-AT) for PTSD. The announcement was in response to a highly anticipated decision by the FDA this week on whether to approve the company’s New Drug Application for MDMA-AT which has attracted sharp criticism from independent advisors.
In June, the FDA Psychopharmacological Advisory Committee (AdComm) voted 9-2 to oppose approval of the proposed therapy. The advisors argued that the data in the clinical trials was insufficient to show that MDMA-AT is an effective treatment for PTSD. The advisors also voted 10-1 that the benefits of MDMA-AT do not outweigh the risks.
After the June advisory meeting, Lykos said it reached out to the FDA to address the criticism raised by AdComm. The company also addressed a separate report issued by the Institute for Clinical and Economic Review (ICER) which found the data was likely not adequate to support FDA approval of the therapy. Both independent advisory groups cited multiple concerns about safety, research bias, and oversight in the clinical trials.
After the AdComm meeting, Lykos says it reached out to the FDA to discuss reservations about MDMA-AT. The company said these discussions would inform the ongoing development of an effective Risk Evaluation and Mitigation Strategy (REMS) drug safety program required by the FDA for medications with safety risks.
In its report to the FDA, ICER noted that in its view, internal oversight structures created by Lykos may not be sufficient. In it’s policy recommendation, the organization, which advises the insurance industry, asserted that “Rigorous certification and oversight of providers is of the highest importance and should include entities other than the manufacturer, such as the American Psychiatric Association and American Psychological Association, to reduce potential conflicts of interest in maintaining the highest standards.”
ICER further advised that Lykos, the manufacturer of the therapy, may play a role, but should not be “the sole agent of certification.” They suggest a possible two-step process for certification that could begin with the manufacturer and be followed by a professional association.
Key Points of the Lykos Strategy
In its August 1 announcement, Lykos said it was “launching an independent advisory board to inform key elements of a potential commercial launch, including therapy training, ethics and healthcare integration.” The company said it planned to work with “select top-tier behavioral health centers that can meet FDA-proposed patient monitoring requirements and provide integrated quality care.” Lykos also said that it would collaborate with other organizations to provide training to therapists.
Lykos noted in its announcement that its New Drug Application (NDA) included results from numerous studies, including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) which examined the efficacy and safety of MDMA-AT versus placebo. The company said that the therapy involved included participants diagnosed with moderate or moderate and severe PTSD, and is the first PTSD treatment to combine a drug and psychological intervention. Both studies met their primary and secondary endpoints, and were published in Nature Medicine.
Lykos observed in its statement that while the practice of psychotherapy is not regulated by the FDA, it is “a regulated field with mandatory reporting requirements and oversight provided by licensing boards and professional societies.” If MDMA-AT is approved, the company says that healthcare professionals providing the therapy “will utilize their clinical judgment to effectively deliver treatment, with appropriate oversight from these governing bodies.” According to Lykos, these measures will exist together with the controls and requirements set forth in the product labeling and REMS program.
“Given the novelty of this approach, we are taking steps to help ensure additional oversight for this drug plus therapy modality, if FDA approved, and to help integrate into the real-world healthcare setting,” said Amy Emerson, Chief Executive Officer at Lykos Therapeutics, in the statement. “It is critical for the millions of people suffering with PTSD, including veterans and survivors of physical and sexual assault, to have access to a potential new treatment option. To this end, we will work with external experts on an independent advisory board, focus our initial commercial rollout on centers of care where there are multiple layers of oversight and collaborate with others around therapy training. This process will establish a strong foundation to ultimately reach more patients in need of access to new treatment options.”
Additional Oversight
Lykos says their independent advisory board to inform the potential commercial launch of MDMA-AT will be comprised of “external experts in corporate and medical ethics, innovation, psychiatry, and military and veteran health.” The company named the advisors, including “Barbara O. Rothbaum, Ph.D., Professor of Psychiatry, Emory University School of Medicine, Brigadier General (Ret) Loree Sutton, M.D., the highest-ranking psychiatrist to serve in the U.S. Army for twenty years who was awarded the Bronze Star, Robert Chesnut, former Assistant U.S. Attorney and author of the book Intentional Integrity: How Smart Companies Can Lead an Ethical Revolution, and others.”
In its announcement, Lykos says it will work with behavioral health facilities to “help ensure these sites are prepared to implement the measures utilized in Lykos’ clinical trials.” The company notes that if approved, MDMA-AT will only be commercially available at care centers that meet all FDA and DEA requirements, such as “nationally accredited centers, veteran healthcare facilities and academic medical centers that have coordinated medical and behavioral health care and layers of oversight.”
In addition, Lykos says its REMS program would “ensure the drug is administered only in certified healthcare facilities that meet the FDA’s proposed requirements.” Some of the centers that plan to be the first to deliver MDMA-AT if approved by the FDA are Emory University, Sheppard Pratt, Hackensack Meridian Health, Pacific Neuroscience Institute and Sunstone Therapies, says Lykos.
Collaborating on Training
According to Lykos, the new independent Advisory Board will advise on the approach to therapist training and how it can be delivered, including opportunities to transfer that training to other organizations. The company says that by collaborating on training, it can leverage Lykos’ clinical trial experience developing MDMA-AT and combine that knowledge with the perspectives of institutions and health systems.
Lykos says it is in discussions about how to begin transitioning training to support the needs of institutions planning to deliver this therapy. “PTSD patients deserve the most effective treatments we can offer, and we want to make sure that we are well positioned to meet their needs,” said Dr. Rothbaum who refers to the full chemical name of MDMA. “Given the promise of midomafetamine-assisted therapy, we have been preparing our center to be an early leader in this potential science-driven combination treatment.”
What the FDA Could Do in Its Decision
There are a number of possible decisions that the FDA could make this week. They could fully approve MDMA-AT, fully deny the NDA, or delay their decision pending the availability of additional data. If approved, MDMA-AT would be the first therapy for PTSD, including a drug, to be approved by the FDA in more than two decades. The FDA will likely mandate and could specify strict REMS to accompany the delivery of MDMA-AT. It could also require additional data to be collected in post-marketing studies. Such requirements could potentially increase costs for Lykos and impact the scope of the therapy. The FDA might also stipulate labeling language and weigh in on the details of DEA rescheduling at both the federal and state level.
If the Lykos NDA for MDMA-AT is rejected, the FDA could issue a Complete Response Letter and detail why the proposed therapy was not approved. It could offer information about how Lykos could address concerns and potentially resubmit the application. The company may choose to reveal this information in its statements after the decision as such letters are typically not made public. If additional clinical trials are required by the FDA, Lykos would need to address the challenge of raising funds for additional research.