Coming Soon
The future of psychedelic medicine may be closer than you think.
MDMA-assisted therapy for PTSD and psilocybin therapy for depression are advancing through FDA review. PMC Psychedelic is preparing now so we can be ready when approval allows.
Why we're telling you about treatments we don't offer yet.
PMC Psychedelic was among the earliest psychedelic medicine clinics in the region. We believe in being transparent about where this field is heading, so that patients who may benefit can plan ahead, and so that we are ready to deliver these therapies the moment FDA approval allows.
We do not offer MDMA or psilocybin therapy at this time, we will wait until they have received full FDA approval. What follows is information on where things stand.
Coming Soon · Not Yet FDA-Approved
MDMA-Assisted Therapy for PTSD
Status: FDA declined first application (Aug 2024). Research and resubmission ongoing. Timeline uncertain.
What it is
MDMA-assisted therapy is a structured clinical protocol that combines a controlled dose of MDMA with psychotherapy sessions in a supervised setting. It is not recreational use. The MDMA is administered to help patients access and process traumatic memories with reduced fear and defensiveness.
What the research shows
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Phase 3 trials showed nearly 70% of participants no longer met PTSD diagnostic criteria after treatment
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FDA granted Breakthrough Therapy designation in 2017; designation remains active
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FDA declined first NDA in August 2024 citing trial design concerns, not lack of efficacy
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Lykos Therapeutics continuing research and pursuing resubmission
Who it's designed for
Clinical trials focused on adults with moderate to severe PTSD, including veterans, first responders, 9/11 survivors, MTA workers, and survivors of assault or complex trauma.
PMC already treats PTSD patients with Ketamine IV Infusion, which is available now and has a strong track record for PTSD symptom relief.
Coming Soon · Not Yet FDA-Approved
Psilocybin Therapy for Depression
Status: Phase 3 trials complete. NDA submission expected late 2026. FDA decision possible late 2026 or 2027.
What it is
Psilocybin therapy uses a synthesized, precise dose of psilocybin administered in a supervised clinical session. Patients rest in a calm environment while the medication produces an inward-focused experience that researchers believe drives neuroplastic changes in the brain. Unlike daily antidepressants, one to three sessions may produce results lasting weeks to months.
What the research shows
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FDA Breakthrough Therapy designation for treatment-resistant depression (2018) and major depressive disorder (2019)
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Phase 3 trials by Compass Pathways have met primary endpoints
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NDA submission expected late 2026 with potential FDA decision to follow within months
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Unlike MDMA, psilocybin is being reviewed as a standalone drug with fewer regulatory complications expected
Who it's designed for
Clinical trials focused on adults with treatment-resistant depression and major depressive disorder who have not responded adequately to antidepressants.
Currently struggling with depression that hasn't responded to treatment? Spravato and Ketamine IV Infusion are available now.
Why PMC Psychedelic will be ready on day one.
We are not waiting for approval to start preparing. Our clinical infrastructure, compliance experience, and patient community position us to offer both therapies quickly and safely when the time comes.
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Compliance Experience
REMS compliance experience through Spravato, the same framework both therapies will likely require
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Clinical Expertise
Over 5,000 psychedelic treatments completed, with clinical protocols and team infrastructure already in place
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Strong Community
Strong existing patient community among those most likely to benefit from MDMA and psilocybin therapy
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Personal Evaluations
Dr. Rueda personally evaluates every patient with a personalized approach when these therapies launch
Get Started
Want to know the moment these therapies become available?
Submit a consultation request and let us know which therapy you're interested in. We will add you to our notification list and reach out as soon as we are able to offer treatment.
In the meantime, our team can discuss current treatment options that may help right now.
PMC Psychedelic · Port Chester, NY · Serving Westchester & Fairfield County
