EMA CMO discusses psychedelics in an interview with ECNP

In a recent interview published by the European College of Neuropsychopharmacology (ECNP), the Chief Medical Officer of the European Medicines Agency, Dr. Steffen Thirstrup, shared insights on the evolving perspective towards psychedelics in medical treatment. Read the full interview here.

He highlighted the historical context of psychedelic restrictions, attributing them more to political factors than scientific evidence, and mentioned the relatively low addiction potential of these substances compared to opioids and central nervous stimulants.

Dr. Thirstrup pointed out the scarcity of innovation in treatments for mental disorders and suggested that psychedelics could offer new possibilities for conditions like treatment-resistant depression and PTSD.

He stressed the critical need for drug developers, encompassing both the pharmaceutical industry and academic researchers, to engage with the EMA at the onset of their developmental processes. He detailed the frequent oversight of considering European regulatory expectations, which differ significantly from those in the U.S. By initiating dialogue with the EMA early, developers can navigate the unique regulatory landscape of Europe, ensuring that any potential challenges or requirements specific to the European context are identified and integrated into the trial designs from the start.

The interview also covered the EMA's recent update of depression guidelines, which now consider psychedelics, and Dr. Thirstrup's participation in the 2023 ECNP New Frontiers Meeting in Nice, where he valued learning from diverse perspectives, including those of patients who have experienced psychedelics.