The FDA is investigating allegations of misconduct in Lykos Therapeutics' studies of its experimental MDMA drug, which failed to win agency approval in early August, according to The Wall Street Journal.
Participants in a trial testing Lykos Therapeutics' experimental ecstasy-based drug previously told the news outlet they felt pressured to report positive outcomes. Some trial subjects also alleged shortfalls in side-effect reporting and researchers illicitly offering MDMA, commonly known as ecstasy.
The drugmaker said it is not aware of researchers illegally distributing MDMA and that its data is reliable.
Lykos submitted a new approval application for its drug midomafetamine after finding symptom reduction among post-traumatic stress disorder patients, but the FDA rejected the therapy Aug. 5 and requested a new clinical trial.
FDA investigators have interviewed four people about the research and whether side effects went unreported, people familiar with the matter told WSJ. The investigation is ongoing.
"Lykos is committed to engaging with the FDA and addressing any questions it raises," a company spokesperson told WSJ.
The drugmaker plans to lay off about 75% of its workforce after the FDA's rejection of its drug application.