FDA Acceptance and Priority Review: Lykos Therapeutics' MDMA-Assisted Therapy Breakthrough for PTSD

In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has granted priority review to Lykos Therapeutics' (formerly MAPS PBC) MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD). This development not only marks a significant leap in mental health treatment but also holds profound implications for companies like Numinus in the field of psychedelic-assisted therapy. 

Understanding the FDA Priority Review

The FDA's priority review is a special designation reserved for drugs that promise substantial improvements in safety or effectiveness compared to standard treatments. In the case of MDMA-assisted therapy, this acknowledgment underscores the urgent need for innovative approaches to address the complexities of PTSD. MDMA-assisted therapy was only submitted as a new drug application to the FDA by non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) in December 2023.

A Glimpse into MDMA-Assisted Therapy

MDMA-assisted therapy, an important and promising venture in mental health treatment, involves the use of midomafetamine capsules (MDMA) in combination with intentional therapy before, during, and after each medicine session. Based on the data from two published Phase 3 studies completed by MAPS and numerous other trials, MDMA-assisted therapy is a real breakthrough in the treatment of PTSD. 

What This Means for Numinus and the Psychedelic Therapy Landscape

Validation of Psychedelic Therapies

The FDA's early acknowledgment of the potential benefits of MDMA-assisted therapy provides a significant boost to the legitimacy of psychedelic therapies. This is good news that we anticipate will pave the way for broader acceptance and integration of these treatments into mainstream mental healthcare.

Expanding Treatment Options

If (and when) approved, this therapy would represent a monumental shift in the available treatment options for PTSD. Companies like Numinus, already at the forefront of psychedelic therapy, may see expanded opportunities to offer innovative solutions for people suffering from post traumatic stress disorder. 

PTSD, a grave mental health condition stemming from traumatic events, grips approximately 13 million Americans each year. Military personnel have a greater prevalence of PTSD than the general population, however, it may not be as widely known that that the largest cause of PTSD is non-combat-related trauma (e.g., sexual violence, unexpected death of a loved one, life-threatening traumatic event or interpersonal violence). Women and marginalized groups bear a disproportionate burden, underscoring the urgency for inclusive and targeted treatment. With this treatment available, Numinus will be able to provide this option for relief that these people need and deserve across our network of clinics.

Heightened Focus on Safety and Efficacy

The FDA's priority review signals a keen focus on ensuring the safety and efficacy of psychedelic treatments. This emphasis aligns with Numinus's commitment to providing evidence-based and responsible psychedelic-assisted therapy.

Psychedelic-Assisted Therapy Training 

With increasing public awareness and acceptance of psychedelic medicine, our training program is pivotal in preparing professionals to meet the demand for responsible and safe MDMA-assisted therapy. As the therapeutic landscape expands, Numinus-trained and certified practitioners will be ready to integrate psychedelic assisted protocols into their practice. This transformative period presents opportunities for collaboration and cements the role of our training programs in moving this type of treatment forward. Learn more about our certification pathway here.

Looking Ahead

We are deeply invested in the transformative power of psychedelics and are thrilled to learn about the FDAs priority review of MDMA-assisted therapy. Our team wholeheartedly believes this development can and will change lives.

Physician Information — Ketamine-Assisted Psychotherapy

What is ketamine-assisted psychotherapy?

As you will likely know, ketamine is an anesthetic and analgesic used widely internationally. Ketamine also has antidepressant and psychedelic effects at certain doses, and international research has increasingly demonstrated that the combination of ketamine with structured psychotherapy can have benefits for a range of mental disorders. The ketamine assisted psychotherapy protocol at Numinus is distributed over approximately 4-6 weeks, depending on the patient’s schedule and how the visits are scheduled. Generally, the therapeutic protocol is expected to include two 50 minute introductory psychotherapy sessions without the use of ketamine, three ketamine dosing sessions of 2.5 hours in duration each followed within 24 hours by 90-minute psychotherapeutic sessions where insights from the ketamine experience are integrated, and a closing 50-minute psychotherapy (non-ketamine) session. Throughout this process, the psychotherapy delivered is focused on support, integrating insights, and identifying and reinforcing change as part of the therapeutic process.

Who is eligible for ketamine assisted psychotherapy?

Though research indicates that ketamine assisted psychotherapy may be effective for a number of mental health indications, Numinus is currently focused on addressing treatment-resistant depression. If you have a patient suffering from treatment-resistant depression that is interested in ketamine assisted psychotherapy, our team will work directly with them to determine whether the patient is a good candidate for treatment by taking a full medical and psychological history. To be eligible for ketamine assisted psychotherapy at Numinus, the patient must be referred by their primary care providers, such as a family physician or nurse practitioner.

What are the contraindications of ketamine assisted psychotherapy?

Those conditions that may make ketamine assisted psychotherapy contraindicated (i.e., potentially unsafe) include, but are not limited to, a history of psychosis (e.g. hallucinations), mania, cerebrovascular or cardiovascular disease, seizure, and severe liver disease. At present, youth, pregnant women and nursing mothers are not eligible for ketamine assisted psychotherapy since the effects of ketamine on pregnancy, nursing children, and youth are unknown. Additionally, the ketamine product monograph lists other risks which will be reviewed with all patients as part of an informed consent process at Numinus.