ARTICLE | Regulation
Committee advisers weren’t convinced Lykos’ psychotherapy combination is either effective or safe for PTSD
By Selina Koch, Executive Editor
June 5, 2024 1:59 AM UTC
![](https://platohealth.ai/wp-content/uploads/2024/06/fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally.gif)
![](https://platohealth.ai/wp-content/uploads/2024/06/fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally.png)
Although there were too many confounding factors to convince FDA’s advisers that Lykos’ MDMA-psychotherapy combination is either effective or safe for PTSD, the outcome is unlikely to read through to other psychedelic therapies in the pipeline.
FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted 2-9 against the assertion that the available data demonstrate the drug-therapy treatment package is effective in patients with post-traumatic stress disorder. The panel voted 1-10 against FDA’s proposed REMS being adequate to achieve a favorable benefit-risk profile…
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://www.biocentury.com/article/652612/fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally