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

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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.


UNLOCK INDUSTRY BREAKTHROUGHS, MENTAL HEALTH TIPS, AND MIND ALTERING INSIGHTS.

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