The U.S. Food and Drug Administration has agreed to review a new drug application for MDMA — commonly known as ecstasy — to be developed for the treatment of post-traumatic stress disorder. (Drug Enforcement Agency)
WASHINGTON — The U.S. Food and Drug Administration has agreed to review a new drug application for MDMA — commonly known as ecstasy — to be developed for the treatment of post-traumatic stress disorder in a supervised clinical setting.
Lykos Therapeutics, a biotechnology research company in San Jose, Calif., announced the FDA granted priority review status for its new drug application for midomafetamine, or MDMA, capsules as a medical treatment for PTSD.
The FDA approves applications by drug manufacturers to develop and commercially market medications in the United States. Priority review means the FDA intends to make a decision within the next six months.
“A priority review designation directs attention and resources to evaluate drugs that would significantly improve the treatment, diagnosis or prevention of serious conditions,” the FDA states on its website.
MDMA is a synthetic drug that acts as a hallucinogen and stimulant, according to the National Institute on Drug Abuse.
Studies have shown a decrease in depression, anxiety and stress among users of certain psychedelic drugs. The symptoms are common to PTSD, which often afflicts military members and veterans who have been in combat and other life-threatening situations.
Veterans with PTSD are at a higher risk for suicide than those without the diagnosis, according to research by the Department of Veterans Affairs.
Among veterans who died from suicide in 2020, the prevalence of PTSD diagnoses was 25%, followed by alcohol use disorder at 19%, according to the VA’s National Veteran Suicide Prevention Annual Report in 2023.
Lykos has described the drug as a class of psychoactive compounds “that are differentiated from classic psychedelics” with “known effects of increasing self-awareness leading to introspection and personal reflection.”
The drug would be administered as “MDMA-assisted therapy,” in combination with mental health counseling and other supportive services, Lykos said.
“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” said Amy Emerson, chief executive officer of Lykos.
PTSD is a mental health condition that can develop when an individual experiences or witnesses a traumatic event.
Military personnel have a higher prevalence of PTSD than the general population, Lykos said in the company’s formal statement about the FDA’s priority review of the drug as a potential treatment since other medications have failed to work.
Lykos said in a formal statement that the FDA plans to decide by Aug. 11 whether to approve MDMA-assisted therapy as a PTSD treatment.
The FDA said Tuesday that it cannot comment on pending applications for new drugs.
MDMA is classified by the Drug Enforcement Administration as a Schedule 1 drug under the Controlled Substances Act, which means it is illegal under federal law and has been determined to have no current acceptable medical use.
But a growing number of veterans have sought MDMA treatment and other psychedelics to address flashbacks, depression and other symptoms related to PTSD.
Rep. Morgan Luttrell, R-Texas, credited psychedelic-assisted therapy for addressing PTSD and other mental health problems that he had after leaving service as a Navy SEAL. Luttrell served from 2007 to 2014 but was medically retired after suffering complications from a traumatic brain injury in a 2009 helicopter crash during training off the Virginia coast.
After leaving the service, Luttrell received assisted mental health therapy with MDMA and ibogaine — both hallucinogens — at a medical facility outside the United States. He said the short-term treatments improved his mental health and saved his marriage.
Luttrell has supported efforts in Congress to fund research into certain psychedelic drugs for the treatment of PTSD and TBI in service members and veterans.
The VA announced in January that it plans to fund clinical trials of psychedelic-assisted therapies using magic mushrooms and ecstasy to treat PTSD.
“Veterans and VA researchers have told us about the potential promise of psychedelics to treat mental health conditions for some time,” Shereef Elnahal, the VA undersecretary for health, said when the VA disclosed plans for the study.
The National Defense Authorization Act for fiscal 2024 also authorized $10 million for the military to conduct similar clinical trials with active-duty service members.
