The FDA headquarters in Silver Spring, Md. (Photo courtesy of FDA) WASHINGTON – Police and firefighters in Arizona who suffer from PTSD could soon use workers’ compensation to cover therapy that involves the psychedelic drug commonly known as ecstasy or molly.
That depends on the Food and Drug Administration, which plans to vote next month on approval of MDMA-assisted therapy for post-traumatic stress disorder.
An FDA advisory committee recommended against approval on June 4. But advocates remain hopeful.
“The question is, will it be August or will it be two to five years from now? It’s up to the FDA how many people die before it’s approved,” said Jonathan Lubecky, a military veteran who took part in a clinical trial a decade ago and now advocates for its wider use.
Given the depression and suicidal thoughts that too often stem from PTSD, he said in an interview, it’s “ludicrous” to keep MDMA away from patients.
Pending FDA approval, the Arizona Legislature added MDMA-assisted therapy to the list of treatments available to first responders with PTSD under the state’s workers’ comp plan.
Gov. Katie Hobbs signed the measure last month.
MDMA (methylenedioxymethamphetamine) is a synthetic substance that acts as both a stimulant and a hallucinogenic, according to the Drug Enforcement Administration. In the treatment context, it is meant to be used with talk therapy.
The drug increases the patient’s self-awareness and tolerance for revisiting distressing experiences, leading to introspection and reflection, according to Lykos Therapeutics, which submitted the new drug application for MDMA-assisted therapy to the FDA in December.Two clinical trials were included in the application. At the end of the second study, 71% of the MDMA group no longer met the criteria for PTSD, compared to 48% of those who received a placebo.“It lifts that fog and then they’re able to process more in therapy,” said Stephanie Miller, a clinical therapist who treats patients in Arizona and Texas virtually.She frequently refers patients for ketamine treatment, another controversial therapy that has gained popularity among first responders in recent years.While legal for doctors to prescribe, ketamine – a short-acting painkiller that makes people feel detached from their environment and […]
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