Lykos Therapeutics, the drug’s manufacturer, said the agency requested an additional phase 3 clinical trial to study the drug’s safety and efficacy, according to an Aug. 9 news release from the company.
In February, the FDA accepted Lykos’ new drug application for midomafetamine capsules for the treatment of PTSD in combination with psychological intervention.
The rejection comes after an FDA advisory committee’s June meeting in which members expressed concern over the trial’s clinical data, trial participants’ history of MDMA use and the contribution of psychotherapy to treatment outcomes.
Three participants in the study told The Wall Street Journal they experienced worsened thoughts of suicide during and after taking the medicine and that those potential side effects were not recorded by researchers.
“Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations for a resubmission seeking regulatory approval for midomafetamine capsules,” the company wrote in the release.
Midomafetamine, also known as 3,4-methylenedioxymethamphetamine, was designated as a Schedule I drug by the federal government under the Controlled Substances Act of 1985, according to Drugs.com.
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