FDA Rejects Lykos Therapeutics' PTSD Drug, Requests Further Trials
FDA rejects Lykos Therapeutics' PTSD drug application, requests additional Phase III trial.
The US Food and Drug Administration (FDA) has released a comprehensive response letter (CRL) on the new drug application (NDA) that US hallucinogenic medicine company Lykos Therapeutics filed for midomafetamine capsules to treat adults with post-traumatic stress disorder (PTSD).
Given that the Psychopharmacologic Drugs Advisory Committee
(PDAC) voted two to nine against MDMA-assisted therapy for PTSD on June 4,
raising concerns regarding safety, cardiovascular risks, and problems with
functional unblinding in trial settings, the news is not surprising.
After reviewing the NDA, the FDA informed the public that it
could not be authorised based on the evidence that had been presented up to
that point. The FDA has asked Lykos to carry out an extra Phase III trial in
order to investigate the safety and efficacy of midomafetamine.
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