midomafetamine (MDMA) / Lykos Therapeutics - LARVOL DELTA

Trends in first-time psychedelic and other hallucinogen use in the United States: Results from the National Survey on Drug Use and Health. (PubMed, Drug Alcohol Depend) - "First-time psychedelic and hallucinogen increased only slightly over the period from 2002 to 2019 though there were notable age-group and substance-specific trends: new use generally decreased among adolescents and increased in among those aged 65 and older. Trends from 2021 to 2023 likewise did not suggest changes in overall new use, but continue to show changing patterns of use across substances and age groups."

Journal

MDMA-assisted Therapy for Fibromyalgia (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Spaulding Rehabilitation Hospital | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial primary completion date • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

MDMA-assisted Therapy for Fibromyalgia (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Spaulding Rehabilitation Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

SAMATI: Social Anxiety MDMA-Assisted Therapy Investigation (clinicaltrials.gov) - P2 | N=90 | Completed | Sponsor: Jason B Luoma | Active, not recruiting ➔ Completed | Trial primary completion date: Aug 2025 ➔ Feb 2025

Trial completion • Trial primary completion date • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

VALLMDMA_001: MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD (clinicaltrials.gov) - P2 | N=5 | Completed | Sponsor: VA Loma Linda Health Care System | Trial primary completion date: Dec 2024 ➔ May 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

MDMA-Assisted Treatment for PTSD, Anxiety, and Depression: A Visualized Literature Analysis over 30 Years. (PubMed, Curr Med Chem) - "This study provides a comprehensive synthesis of the past thirty years of research on MDMA-AT in the treatment of PTSD, anxiety, and depression, identifying major research trajectories and critical challenges in the field. While current findings highlight the therapeutic promise of MDMA and its translational potential, further research is needed to improve trial design, enhance sample diversity, and evaluate long-term effects in order to support the standardization and evidence-based integration of MDMA- assisted therapy into clinical practice."

Journal • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Optimi Health Obtains U.S. FDA Drug Establishment Registration (Yahoo Finance) - "Optimi Health Corp...has received its U.S. FDA Establishment Identifier (FEI) number—a key regulatory step for engaging in FDA filings and compliant supply into the United States. According to the U.S. Food and Drug Administration's Drug Establishments Current Registration Site (DECRS), 'The publication is a list of currently registered establishments which manufacture, prepare, propagate, compound, or process drugs that are distributed in the U.S. or offered for import to the U.S.' Optimi is now publicly listed among these registered drug production facilities. This recognition comes as 25 U.S. states have considered psychedelic legislation through more than 74 bills, underscoring the growing need for compliant, scalable, and cost-effective manufacturing to support responsible access to substances like MDMA and psilocybin."

FDA event • CNS Disorders • Psychiatry

MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: University of New Mexico | Active, not recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Substance Abuse

MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: University of New Mexico | Trial completion date: Nov 2025 ➔ Nov 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2027

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Substance Abuse

A Review of the Federal Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics. (PubMed, Perm J) - "The authors will include a review of the FDA's recent denial of the New Drug Application for 3-4-methylenedioxymethamphetamine with adjuvant psychotherapy for posttraumatic stress disorder from Lykos Therapeutics of San Jose, California (formerly the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation)...These legislative efforts reflect an alternative and less expensive pathway, but they do not make as thorough of an evaluation for drug safety. The authors will propose that the FDA remains the appropriate agency to evaluate and approve the use of this class of proposed therapeutics."

Journal • Review • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

My Bad, You Got This: witnessing, therapist attitude and the synergy between psychedelics and inner healing intelligence in the treatment of trauma. (PubMed, Front Psychol) - "The MAPS (Multidisciplinary Association for Psychedelic Studies) sponsored MDMA-assisted therapy protocol has had greater success in treating trauma in preliminary clinical trials than any prior psychotherapeutic, pharmacologic, or combined approach...This makes trusting one's inner healing intelligence a process of feeling witnessed. In both settings, the therapist's willingness to acknowledge her technical limitations or failings, coupled with a conviction that the participant/patient's primary need in processing trauma is to feel witnessed, facilitates the integration of dissociated experience."

Journal • Mood Disorders • Psychiatry

A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Remedy | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Nov 2024 | Trial primary completion date: Jun 2024 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

VALLMDMA_001: MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: VA Loma Linda Health Care System | Recruiting ➔ Active, not recruiting | N=10 ➔ 5

Enrollment change • Enrollment closed • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Numinus Wellness Comments on FDA Decision on New Drug Application for MDMA-Assisted Therapy for PTSD (Canada Newswire) - "Numinus Wellness Inc...comments on the U.S. Food and Drug Administration's ('FDA') decision to not approve Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with post-traumatic stress disorder ('PTSD'). According to a news release issued by Lykos Therapeutics, the FDA has requested that an additional Phase 3 study be conducted to study the safety and efficacy of MDMA further."

FDA event • CNS Disorders • Post-traumatic Stress Disorder

Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD (PRNewswire) - "Lykos Therapeutics...announced that the U.S. Food and Drug Administration ('FDA') has issued a complete response letter ("CRL") for the new drug application ('NDA') for midomafetamine capsules for the treatment of post-traumatic stress disorder ('PTSD') in adults. The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date. The FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine. Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission seeking regulatory approval for midomafetamine capsules."

CRL • Post-traumatic Stress Disorder

Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted Therapy for PTSD (PRNewswire) - "Lykos Therapeutics...announced that on June 4, 2024, the U.S. Food and Drug Administration's ('FDA') Psychopharmacologic Drugs Advisory Committee ('PDAC') will review data supporting the new drug application ('NDA') for midomafetamine (MDMA) capsules used in combination with psychological intervention ('MDMA-assisted therapy') for adults with post-traumatic stress disorder ('PTSD'). This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years....PDAC will review 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, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider, versus placebo with psychological intervention in participants diagnosed with severe or moderate to severe PTSD, respectively."

FDA event • Post-traumatic Stress Disorder

MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: University of New Mexico | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Substance Abuse

Lykos Therapeutics Announces Completion of European Phase 2 Study for MDMA-Assisted Therapy for PTSD (PRNewswire) - "Lykos Therapeutics...announced the completion of a European Phase 2 study (MP18), an open-label, multicenter feasibility study of investigational midomafetamine (MDMA) capsules used in combination with psychological intervention ('MDMA-assisted therapy') for adults with post-traumatic stress disorder ('PTSD')."

Trial completion • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

MDMA-assisted Therapy for Fibromyalgia (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Spaulding Rehabilitation Hospital | Initiation date: Mar 2024 ➔ Aug 2024

Trial initiation date • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Psychedelic Therapy: A Primer for Primary Care Clinicians-3,4-Methylenedioxy-methamphetamine (MDMA). (PubMed, Am J Ther) - "Phase III trials suggest that MDMA is superior to antidepressant medications for treating PTSD. Now that MAPS has officially requested the Food and Drug Administration to approve MDMA as a treatment for PTSD, legal MDMA-assisted therapy may become available as soon as 2024."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders (ANZCTR) - P2 | N=24 | Recruiting | Sponsor: Monash University | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2023

Enrollment open • Trial initiation date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: MAPS Europe B.V. | N=40 ➔ 21

Enrollment change • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD (PRNewswire) - "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'). 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.....The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2)..."

NDA • PDUFA date • CNS Disorders • Post-traumatic Stress Disorder

Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: MAPS Europe B.V. | Enrolling by invitation ➔ Completed

Trial completion • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

VALLMDMA_001: MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: VA Loma Linda Health Care System | Trial completion date: Dec 2023 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder