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The FDA Meeting of the Psychopharmacologic Drugs Advisory Committee evaluating the New Drug Application for MDMA is happening now. How do clinicians feel about this potential treatment for PTSD?
CLINICAL CONVERSATIONS
The US Food and Drug Administration (FDA) Meeting of the Psychopharmacologic Drugs Advisory Committee evaluating Lykos Therapeutic's New Drug Application for MDMA is happening now. How do clinicians feel about this potential treatment for posttraumatic stress disorder (PTSD)? We spoke to Rachel Dalthorp, MD, MHSA, a board-certified psychiatrist who is passionate about innovative treatments, to get her perspective.
PT: What is the role of psychedelics in psychiatry, in your opinion?
Rachel Dalthorp, MD, MHSA: Patients are suffering with mood and anxiety disorders and looking for differentiated treatment options. Many have failed to respond to traditional treatments or experienced intolerable adverse effects.
Psychedelics, as a class, are promising treatment options for difficult to treat depressive disorders, suicidal ideation, certain substance use disorders and anxiety disorders such as PTSD and end of life anxiety.
These are devastating illnesses; patients are looking for hope and recovery. Dissatisfied with traditional treatments, and desperate to feel better, they are looking to use these substances without the support of a mental health clinician and/or outside of a supervised medical setting where monitoring and psychologic support can be provided, and that worries me. As clinical research progresses and psychedelics demonstrate safety and efficacy in practice, I believe we will be able to prescribe them to be provided under medical supervision and in many cases, in combination with psychotherapy.
PT: What do you think of the safety and efficacy of MDMA-assisted therapy?
Dalthorp: I think MDMA-assisted therapy is a breakthrough with the potential to provide patients with months of symptom remission with periodic maintenance treatment, if needed. I believe it is safe when provided to appropriately diagnosed patients, by clinicians adhering to evidence-based practices for patient safety and in compliance with controlled substance prescribing. I would be supportive of a REMS program for all psychedelics with compliance standards and regulations to minimize the risk of diversion and harm.
PT: What should clinicians know as this goes to the FDA?
Dalthorp: MDMA-assisted therapy approval by the FDA will be a revolutionary development, signify a new era for treating mental illness, and give patients and their families hope for the future. Approval could also open the door for additional research into other natural and synthetic psychedelics and potentially, the development of additional psychedelic like synthetic medications—with or without the classic, altered state classic psychedelics induce.
With FDA approval, we can begin the process of seeking adequate insurance coverage to improve access to care for those without the financial resources to pay out of pocket. New codes for medication delivery, monitoring, and psychotherapy must be implemented to make a significant impact at scale.
PT: Thank you!
Dr Dalthorp is the executive medical director of LifeStance Health and a reproductive psychiatrist at Balance Women’s Health. She is passionate about women's mental health, treatment resistant depression, and innovation in psychiatry.