With their new name to reflect the journey their patients undergo when treated with psychedelic drugs, Tryptamine Therapeutics (ASX: TYP) has confirmed that all patients suffering from fibromyalgia that took their TRP-8802 drug, an oral psilocybin formulation, demonstrated significant pain relief. 

The study, conducted in collaboration with the University of Michigan (UOM), was presented at the International Association for the Study of Pain (IASP) 2024 World Congress in the Netherlands.

Fibromyalgia, a chronic condition characterised by widespread pain, affects approximately one million Australians and nearly 10 million people in the United States. Current treatment options for fibromyalgia are limited and often ineffective, leaving many patients to manage their symptoms with opioids and other medications that can carry severe side effects.

The Phase 2a trial involved five patients who received two doses of TRP-8802, accompanied by psychotherapy, over a period of two weeks. The results, measured one month after the final dose, were remarkable: 100% of participants reported a clinically meaningful reduction in pain severity, sleep disturbances, and pain interference. Additionally, patients experienced improvements in various quality-of-life metrics, such as enhanced physical activity, better sleep, and increased ability to engage in daily social activities. Notably, four out of five patients also reported a reduction in anxiety and improved cognitive abilities. 

In one case, a patient who had lost their sense of smell due to a COVID-19 infection in 2021 reported that this ability had returned following the psilocybin treatment.

These findings underscore the potential of psychedelic-assisted therapy as a novel and effective treatment pathway for fibromyalgia, especially when compared to the inadequacies of current treatment options. The trial’s success also strengthens Tryp’s intellectual property position and lays the groundwork for further clinical trials, including a planned Phase 2 study using TRP-8803, an IV-infused psilocin formulation, set to commence in the first half of 2025.

Psilocybin, the active compound in TRP-8802, is a naturally occurring psychedelic substance found in certain species of mushrooms. Traditionally known as a recreational drug, psilocybin has been stigmatised due to its classification as an illicit substance. However, recent years have seen a resurgence of interest in psilocybin as a potential therapeutic agent, particularly for mental health conditions such as depression, anxiety, and PTSD. 

In the context of fibromyalgia, psilocybin’s ability to alter perception and cognition may help patients reframe their experience of pain and improve their overall mental and physical well-being. The combination of psilocybin with psychotherapy, as demonstrated in Tryp Therapeutics’ trial, offers a holistic approach to treating the condition by addressing both the physical and psychological aspects of the disease.

“These results highlight that psychedelic-assisted therapy may achieve an improved patient outcome through treating the cause of fibromyalgia rather than the limited relief to select symptoms provided by current treatments,” said Tryp CEO, Jason Carroll. 

“Through this trial, we have demonstrated that psychedelic-assisted therapy may offer an improved future for fibromyalgia patients across Australia and globally.”

The trial’s success is a significant step forward for Tryptamine Therapeutics as it continues to explore the potential of psychedelic compounds in treating chronic pain conditions.