In the psychedelic realm of drug development, it’s not all rainbows and sunshine. While some companies like Lykos Therapeutics and Compass Pathways have faced setbacks that resulted in layoffs (cue the sad trombone), Johnson & Johnson is riding high with their ketamine-derived superstar, Spravato. This nasal spray is expected to hit blockbuster status, laying the groundwork for new psychedelic treatments to follow.
Enter Cybin, a Toronto-based company charging forward with a psilocin candidate, CYB003, aimed at tackling major depressive disorder. Taking notes from the FDA’s playbook, Cybin is incorporating short primary endpoints, ensuring a psychedelic-naïve population, and perfecting the art of thorough blinding in their clinical trials. Their secret sauce? Monitored sessions complete with soothing tunes, where sharp-eyed monitors can usually spot who’s on the psychedelic magic carpet ride and who’s just got a dud ticket.
To keep things above board, Cybin records these sessions and employs AI to keep an eye out for any monkey business, ensuring that no one sneaks in bias like a sneaky cat burglar. They’re also in cahoots with the FDA thanks to a breakthrough therapy designation, allowing for some quality back-and-forth on development strategy. Cybin plans to roll out a risk evaluation and mitigation strategy (REMS) program for CYB003, similar to the successful model used by Spravato, as they dream of seamlessly integrating into existing treatment centers.
With potential changes in leadership at the HHS/FDA, there’s a hopeful buzz in the air about regulated psychedelics becoming a real-life option. So, while some companies are licking their wounds, others are psychedelically surging ahead, ready to change the mental health landscape one
Reference: https://www.lifescienceleader.com/doc/fda-s-psychedelic-reckoning-0001
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