Saturday, June 15, 2024

Post-Traumatic Stress Disorder Treatment: ICER Criticizes Lykos Therapeutics’ Therapy for Trial Design Issues

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The Institute for Clinical and Economic Review (ICER), which usually focuses on the cost-effectiveness of new therapies, has taken an unusual step by sharply criticizing the design and conduct of clinical trials for Lykos Therapeutics’ psychedelic therapy for post-traumatic stress disorder (PTSD). ICER’s latest evidence report on Lykos’ MDMA-assisted psychotherapy for PTSD highlights significant concerns, including “functional unblinding in the clinical trials and additional concerns around trial design and conduct.” These issues, according to ICER, prevent them from delivering a reliable assessment of the therapy’s benefits and harms.

Lykos Therapeutics’ approach involves administering MDMA, a powerful psychoactive substance, as part of a comprehensive therapeutic protocol designed to address post-traumatic stress disorder. MDMA, the active ingredient in midomafetamine capsules, is a Schedule 1 controlled substance commonly known by its street name ecstasy or molly. When used recreationally, MDMA is known for its euphoric and empathogenic effects, which enhance emotional connectivity and reduce fear. Lykos harnesses these properties in a clinical setting to facilitate psychological intervention, creating a supportive environment where patients can process traumatic experiences more effectively.

PTSD is a debilitating condition that affects nearly all aspects of an individual’s life, including mental health, physical health, relationships, and overall functioning. Symptoms of PTSD can include severe anxiety, flashbacks, nightmares, and uncontrollable thoughts about the traumatic event. These symptoms often persist for years and can significantly impair a person’s ability to lead a normal life. Traditional therapeutic options for post-traumatic stress disorder include various forms of psychotherapy, such as cognitive-behavioral therapy (CBT), and pharmacological treatments, such as selective serotonin reuptake inhibitors (SSRIs). However, these treatments are not effective for all patients, and many continue to suffer from the debilitating effects of PTSD despite receiving standard care.

Innovative Post-Traumatic Stress Disorder Treatment Combining Drug and Therapy

Lykos’ MDMA-assisted psychotherapy aims to fill this treatment gap by offering a novel approach that combines the pharmacological effects of MDMA with structured psychological support. In a controlled clinical setting, patients receive MDMA in a carefully monitored dose, followed by guided therapy sessions. The role of MDMA in this context is to reduce fear and defensiveness, increase emotional engagement, and facilitate the therapeutic process. By creating a state of heightened emotional openness and reducing anxiety, MDMA allows patients to confront and process their traumatic memories in ways that are often not possible with conventional therapies.

The process begins with preparatory sessions where the therapist builds a trusting relationship with the patient and provides education about the effects of MDMA. On the day of the MDMA session, the patient takes the drug under the supervision of trained therapists in a safe and controlled environment. These sessions typically last for several hours, during which the patient engages in deep, meaningful therapeutic work. The supportive presence of the therapists helps the patient navigate the emotional intensity of the experience and ensures safety throughout the session.

Following the MDMA session, patients participate in integration sessions where they process the insights and emotions that arose during the therapy. These sessions are crucial for translating the experiences of the MDMA session into lasting psychological and behavioral changes. The integration process helps patients make sense of their traumatic memories, reduce their emotional impact, and develop healthier coping mechanisms.

Post-Traumatic Stress Disorder

Controversial Yet Promising Treatment for Post-Traumatic Stress Disorder

Despite its promise, MDMA-assisted psychotherapy is not without controversy, largely due to the stigma associated with MDMA as a recreational drug. Its classification as a Schedule 1 substance implies that it has a high potential for abuse and no accepted medical use. However, growing evidence from clinical trials suggests that when used in a controlled therapeutic context, MDMA can be both safe and effective. The therapy has shown promising results in reducing post-traumatic stress disorder symptoms, improving quality of life, and fostering long-term recovery.

The current therapeutic options for PTSD are insufficient for many people, leaving a substantial unmet need in the mental health field. Traditional medications and psychotherapies often fall short in providing relief, particularly for individuals with severe or chronic post-traumatic stress disorder. MDMA-assisted psychotherapy offers a new avenue of hope for these patients, providing a potentially transformative treatment that addresses the root causes of their trauma.

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As Lykos Therapeutics advances its clinical trials and prepares for FDA review, the therapy’s potential benefits must be weighed against the risks and ethical considerations of using a controlled substance in treatment. The ongoing debate about the role of psychedelics in medicine highlights the need for rigorous scientific evaluation and thoughtful regulatory oversight. If approved, MDMA-assisted psychotherapy could revolutionize the treatment landscape for post-traumatic stress disorder, offering a new standard of care for a condition that has long been challenging to treat effectively.

ICER Report Adds Pressure as FDA Reviews First Psychedelic-Assisted PTSD Therapy in 25 Years

ICER’s report is especially impactful given the timing. Lykos is just weeks away from an FDA advisory committee meeting, which will be the first to consider a psychedelic-assisted therapy and the first new approach to treating post-traumatic stress disorder in 25 years. This puts significant pressure on the evaluation process, as the therapy’s approval could set a precedent for the entire psychedelic medicines sector.

One of the primary challenges in developing psychedelic therapies is the difficulty in designing blinded control studies. The overt effects of psychedelics on the brain make it nearly impossible to create a true placebo group, as participants can often distinguish between the active drug and a placebo. This issue has been a significant hurdle for developers and regulators alike.

Lykos conducted two phase 3 trials of their MDMA-assisted psychotherapy (MAPP1 and MAPP2), which were published in the journal Nature Medicine. Despite these publications, ICER expressed that it could not assess the extent to which bias influenced the reporting of benefits or the frequency of misreporting harms. Consequently, ICER stated it was unable to arrive at a cost-effectiveness decision regarding the therapy.

David Rind, ICER’s Chief Medical Officer, emphasized the severe nature of post-traumatic stress disorder and the inadequacy of current treatment options. He stated, “It will be incumbent on regulators with complete access to primary data to carefully evaluate whether MDMA-AP has been proven safe and effective.” This statement underscores the importance of thorough regulatory review, especially when pioneering new therapeutic approaches.

Lykos Challenges ICER Critique as FDA Nears Decision on MDMA Therapy for PTSD

Lykos has pushed back against ICER’s findings, arguing that the health technology assessment (HTA) body did not include meaningful input from groups representing patients, caregivers, and providers who have valuable perspectives on the needs of those living with post-traumatic stress disorder. Furthermore, Lykos highlighted that it had consistently sought and received feedback from the FDA throughout the development of MDMA-AP.

The U.S. FDA is scheduled to complete a priority review of Lykos’ MDMA-assisted psychotherapy by August 11th. If successful, Lykos will be the first to bring a therapy based on psychedelic medicine to approval, potentially revolutionizing the treatment landscape for post-traumatic stress disorder and other mental health disorders. However, deliberations on the cost-effectiveness of the approach and the financial viability of Lykos’ business model will have to wait. ICER has scheduled a public meeting for May 30th to discuss its latest evidence report on MDMA-AP. This meeting will be crucial for stakeholders, as it will address the broader implications of the findings and the potential pathways forward for psychedelic-assisted therapies.

In summary, while Lykos’ MDMA-assisted psychotherapy holds promise for treating post-traumatic stress disorder, the concerns raised by ICER regarding trial design and conduct highlight the complexities and challenges of introducing new therapies. The upcoming FDA review and ICER’s public meeting will be pivotal in determining the future of this innovative approach, balancing scientific rigor with the urgent need for effective post-traumatic stress disorder treatments.


Resource: Institute for Clinical and Economic Review, May 15, 2024

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