Dear Sunstone Community,
It has been a pivotal couple of weeks for the field of psychedelic-assisted therapy (PAT) following the FDA advisory committee meeting around FDA approval of MDMA-AT for PTSD. While there has been meaningful dialogue among individuals both within and outside of the psychedelic community — dialogue that is crucial in addressing the complex challenges of this innovative treatment– many questions remain unanswered.
While the committee’s vote is not indicative of the FDA’s official decision, which is expected in August, I am not surprised that we are at this inflection point: psychedelic-assisted therapy introduces a shift in the paradigm of medicine, specifically what counts as disease and health. The current medical system and regulatory framework are not fully prepared to address a treatment model that involves a combination of drug and therapy. MDMA-assisted therapy is a complex, nuanced form of care that is unlike any treatment currently available.
Prior to founding Sunstone, I was an oncologist for 20 years and treated thousands of patients, many of whom were suffering as much emotionally as they were physically. In medical school, there was no discussion of growth or struggle as a way to improve mental health, as it is not part of the lexicon. With a background in clinical research, including a fellowship and faculty position at the NIH, I founded Sunstone because I saw the potential of psychedelic therapy to help patients in their holistic growth and healing.
Upon seeing such transformative results, we have since expanded our work considerably, anticipating a total of 11 open trials in 2024 with additional trials planned for 2025. We have worked across different psychedelic compounds (psilocybin, ketamine, MDMA, 5-MeO-DMT, LSD), multiple indications, and patient groups including oncology patients and veterans. Over the past year at Sunstone, we have administered more treatments using non-ketamine psychedelic-assisted therapy in a medical setting than any other organization in the country.
While Sunstone did not participate in the Lykos’ Phase 2 and 3 trials, we have treated many of the patients in the Expanded Access Program for MDMA-Assisted Therapy for PTSD, and I have witnessed firsthand the healing ability of this treatment. While I recognize the profound impact of MDMA-assisted therapy, I also understand concerns about the complexity inherent with its delivery.
Sunstone is dedicated to clinical research for PAT and our work has never been more important. We understand firsthand the role of therapy, need for safety, and what comprehensive care looks like. Through our deep experience, we have a validated perspective on the delivery model necessary to ensure patient safety and efficacy:
- Psychedelics do not heal on their own and effective treatment requires skilled mental health professionals to deliver safe psychological support and insight
- Trauma can emerge at any time and therapists must be well-prepared to manage it
- Group therapy can enhance the treatment as knowing you are on a shared journey facilitates healing
- Rigorous screening protocols are critical and will lower the risk of adverse effects
- Compassionate care is not time bound, patients need ongoing support post treatment
MDMA is not a magic bullet and won’t be suitable for everyone. But it will be life-changing for many people who have suffered for years, sometimes decades. We have a unique opportunity to embrace the complexity of this treatment and develop the necessary safety, training, and operational standards to deliver this care to the millions of individuals suffering with PTSD. If done properly, MDMA assisted therapy will be transformative for patients, providing the first new treatment for PTSD in over 20 years.
Our focus remains on improving the understanding of PAT and doing more to ensure safe, efficacious delivery in the real world. As always, Sunstone Therapies will continue to conduct clinical trials with psychedelic-assisted therapy to develop the data supporting these much needed advancements.
With love and rigor,
Manish
Manish Agrawal, MD
CEO & Co-Founder of Sunstone Therapies
