MDMA therapy didn’t get FDA approval. Now what?
The FDA declined to approve the new treatment submitted by Lykos Therapeutics, an organization that develops innovations to “transform mental healthcare,” deciding that there still isn’t enough evidence of benefit to outweigh the risks. The decision will have far-reaching ripple effects.
Some psychedelic advocates will have to put celebrations they’ve been planning for decades on pause; others will rejoice at dodging the bullet of Lykos’s spiritually inflected therapy protocol being the one that breaks the dam of psychedelic treatment … MAPS began as a non-profit, but launched a separate for-profit arm in 2014, called the MAPS public benefit corporation. The corporation was dedicated to winning FDA approval for MDMA, and eventually, bringing it to market. In early 2024, the MAPS public benefit corporation rebranded itself as Lykos Therapeutics…
Original Article (Vox & Lykos):
MDMA therapy didn’t get FDA approval. Now what? & Lykos Therapeutics announces complete response letter for midomafetamine capsules for PTSD
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