The California-based biotech firm confirmed the FDA determined the new drug application could not be approved based on data submitted to date, asking for an additional Phase 3 trial “to further study the safety and efficacy of midomafetamine,” which is also known as MDMA or Ecstasy. Photo courtesy of the Drug Enforcement Administration
The U.S. Food and Drug Administration has denied an application from Lykos Therapeutics for use of MDMA, an ecstasy drug, to treat post-traumatic stress disorder.
The California-based biotech firm confirmed Friday the FDA determined the new drug application would not be approved based on data submitted to date. Advertisement
The agency said it requires an additional Phase 3 trial “to further study the safety and efficacy of midomafetamine,” which is also known as MDMA.
The company said it plans to ask the FDA to reconsider the decision, which was issued Friday.
“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 San Jose company said in the statement.
Lykso management said the issues identified by the FDA in Friday’s complete response letter or CRL, are similar to those raised in early June.
The company is taking issue with the structure and conduct of the FDA’s June 4 Advisory Committee meeting, adding “[the] FDA itself has acknowledged potential problems with the advisory committee process and has opened a public docket seeking comments on how it can be improved.” Advertisement
The advisory committee at the time voted 9-2 not to recommend FDA approval of the treatment, which would work alongside talk therapy.
The committee in its findings, contended Lykos did not adequately record all aspects of the treatment during the trials.
“Thus, the applicant excluded the majority of adverse events typically included with an abuse potential evaluation,” the committee said in its 83-page ruling at the time.
Had it been approved, it would have marked the first new treatment for PTSD in over two decades.
MDMA is commonly taken as an illicit drug but there have been pushes to explore its use as a treatment for PTSD.
The synthetic drug “has effects similar to stimulants like methamphetamine, although some researchers and organizations consider MDMA to be a psychedelic drug because it can also mildly alter visual and time perception,” according a definition by the National Institutes of Health.
