The inside story of how Lykos’ MDMA research went wrong

aDuring a heated Food and Drug Administration advisory committee meeting last week, regulators repeatedly expressed frustration that Lykos, a company seeking approval for MDMA-assisted therapy to treat PTSD, failed to complete instructions monitoring and detecting positive feelings such as ‘euphoria’ that could lead to be used to provide insight into the drug’s addiction potential.

The missing data was “a major problem,” according to clinical reviewer David Millis.

Lykos executives said they had simply misunderstood the FDA’s instructions, but three former employees told a different story. The company had long been aware that it needed to collect such data, they said, and simply failed to do what was needed amid the widespread disorganization. Employees described waiting in vain for approval of a protocol for collecting the data, while executives seemed distracted by other issues.