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.

Honoring Veterans and Addressing PTSD

As Veterans Day arrives, it's not just a time for gratitude but also a moment to shine a light on the mental health challenges faced by those who have served in the military. On a recent episode of KSL’s Dave & Dujanovic, hosts Debbie Dujanovic and Dave Noriega delved into the topic of Veteran mental health, particularly post-traumatic stress disorder (PTSD), with Numinus therapist John Ellis.

The discussion opens with personal stories, including Dave's revelation about his grandfather's World War II experience, emphasizing the often unspoken struggles that veterans carry. John Ellis, a therapist with a background in the United States Air Force Reserves, shares insights into the importance of storytelling for veterans and the therapeutic value of sharing experiences.

"A lot of veterans do keep things inside. But they have stories to tell. And when they start to tell them, it does help." John says.

Fostering an environment of connection, empathy, and emotional understanding, the need for vets to share their experiences is paramount. Our collective society's attentive listening becomes pivotal in acknowledging the importance of veterans' narratives. So, what first steps can we take? 

Let’s start with compassion. Creating a safe and supportive environment to empower veterans to openly express their feelings will help them navigate the path towards healing.

But it isn’t all that simple to create this safe space. Veterans face challenges when opening up about the past, particularly the painful memories. These experiences don’t always flow from the memory into a story - they are sometimes haunting, and dig up old wounds. "We need to help them start telling their stories a little bit. And when they do, we need to listen. It does help them, and it's hard to tell them. Even the good ones." John continues to say. Many people feel sensitive about asking questions, fearful of saying something wrong or triggering. However, there is a balance, and approaching the conversation with delicacy, kindness, and respect can make a veteran feel appreciated. Think about starting by saying something like this: “I understand that talking about your experiences in combat can be challenging, but I want you to know that if you ever feel the need to share or discuss anything, I am here to listen without judgment. Your feelings and experiences are important, and if you choose to open up, this is a supportive space. I appreciate what you've done, and I'm here whenever you're ready.”

For veterans, the emotional connection formed through shared narratives can also be built through engagements such as individual therapy, group sessions, or community resources. "There's that emotion and empathy that can be formed in connection. I think that's really where it starts, whether it's in a therapeutic relationship, just one-on-one with a family member, or amongst veterans - combat or otherwise."  John explains. 

When discussing signs of PTSD,  common indicators include flashbacks, hypervigilance, night terrors, existential dread, and fear that can linger, making it difficult for veterans to feel safe. To begin working through these unwanted feelings, starting with the Veterans Affairs (VA) system is always a solid first step. 

The door is wide open at Numinus, where we provide therapy and utilize treatments like ketamine-assisted therapy, known for its effectiveness in reducing symptoms of PTSD and suicidal thoughts. Many Numinus therapists and staff are veterans themselves, and we always do our best to pair vets-to-vets for an added layer of empathy.

At Numinus, we strongly believe in the power of psychedelic therapy. Ongoing research favors ketamine and other psychedelic medicines, such as psilocybin and MDMA, in treating mental health conditions. Numinus is helping carry the torch for this work, alongside and partnered with long-standing companies like MAPS (Multidisciplinary Association for Psychedelic Studies). The promising results from recent studies show psychedelics, when coupled with talk therapy, have a highly positive impact in relief from depression, anxiety, PTSD, and more.   

We really have learned, from the 70s to now. There really is a lot of research and some real expertise – and there are people that really know how to help navigate your experience," John says. "We’re [Numinus] really helping people rewire their brain from that trauma - that medicinal kind of regeneration of neurons that happens during a psychedelic experience.

As we reflect on Veterans Day, let's carry forward a renewed commitment. Acknowledging the struggles of veterans and the importance of mental health, we extend our gratitude and encouragement. Together, let us foster a compassionate environment, embracing the healing potential of both shared narratives and therapeutic interventions. 

If you or someone you know is a veteran facing mental health challenges, remember, seeking support is a courageous and vital step. Your well-being matters, and the journey towards healing is a shared endeavor.