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San Jose based Lykos Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder (“PTSD”).

MDMA is commonly known as ecstasy (tablet form), and molly or mandy (crystal form). MDMA was first synthesized in 1912 by Merck. It was used to enhance psychotherapy beginning in the 1970s and became popular as a street drug in the 1980s. [

The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August 11, 2024. If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.

The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention versus placebo with therapy in participants diagnosed with severe or moderate to severe PTSD, respectively.

Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.The primary endpoint for both studies was to assess changes in PTSD symptom severity as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (“CAPS-5”). The key secondary endpoint of both studies was to assess improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (“SDS”). No serious adverse events were reported in the MDMA group in either study.

The FDA grants priority review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy has not been established for the treatment of PTSD. Investigational MDMA-assisted therapy is also being studied in other indications.

PTSD is a serious mental health condition that can develop when a person experiences or witnesses a traumatic event. PTSD affects approximately 13 million Americans each year with women and disadvantaged or marginalized groups more likely to be affected.

Military personnel also 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). In addition to the significant personal impact, PTSD has an enormous economic impact resulting in an annual cost of over $232 billion in the United States.

Trauma-focused talk therapy, which concentrates on memories of the traumatic event or thoughts and feelings associated with the traumatic event is first-line treatment for PTSD , which can be used alone or in combination with medication. There are two SSRIs approved for the treatment of PTSD (sertraline and paroxetine). Studies have shown talk therapy lessens the severity of PTSD symptoms, however improvements in functioning and quality of life have been modest. Trauma-focused talk therapy is associated with a high risk of dropout and lingering symptoms which occur in as many as two-thirds of people who complete treatment.  

Current treatments for PTSD are “reasonably efficacious” however many people don’t respond to treatment or stop treatment early, underscoring the urgent need for new evidence-based therapies and approaches to address this important public health issue. While there have been advancements in the management of PTSD, there have been no new drug treatments approved by the FDA in over twenty years.

In the 1970’s and early 1980’s MDMA was used in conjunction with talk therapy by mental health providers to enhance patients’ access, processing, and communication of difficult emotions and experiences. However, in 1985, the U.S. Drug Enforcement Administration (“DEA”) made MDMA a Schedule I drug under the Controlled Substances Act preventing it from being used for recreational or medical use.

Since then, research has shown the unique properties of MDMA allow it to act as a powerful catalyst to support psychotherapy by helping diminish the brain’s fear response allowing people to access and process painful memories without being overwhelmed. However, additional clinical trials would be needed to secure regulatory review and potential approval.

Lykos pioneered the first randomized, double-blind, placebo controlled clinical trials evaluating the efficacy and safety of MDMA-assisted therapy as an investigational modality using midomafetamine (MDMA) in combination with psychological intervention to treat PTSD.