The U.S. Food and Drug Administration has rejected approval of the psychedelic drug MDMA for the treatment of PTSD, ending any prospect of the controversial mind-altering drug, also referred to as ecstasy or molly, being legally included in modern medicine.
San Jose-based drugmaker Lykos Therapeutics said the FDA informed the corporate that the drug “cannot be approved based on the data presented to date” and requested a further, advanced-stage study that would take several years and price thousands and thousands of dollars, in keeping with the Associated Press. The drugmaker said it will ask the agency for a re-examination.
By rejecting the applying, the FDA sent a robust signal that it’s exercising extreme caution when evaluating using psychedelics for therapeutic purposes. The FDA is more likely to review additional applications in the approaching years.
In an earlier FDA review, scientists wrote that patients who received MDMA and talk therapy experienced “rapid, clinically meaningful and durable improvements in their PTSD symptoms.”
However, additionally they called the study “difficult to interpret” since it was hard to say whether the advance got here from the drug or the talk therapy. They also raised several safety concerns, including the cardiac risks and abuse potential of MDMA.
On Friday, the FDA said the brand new drug application had “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication.”
Research for the prescription capsule was conducted at UC San Francisco and funded by enterprise capital—with the prospect of patents and profits. The project began many years ago in a converted three-bedroom house on Mission Street in Santa Cruz, rented by Rick Doblin and the nonprofit group Multidisciplinary Association for Psychedelic Studies (MAPS).
If approved, MDMA-assisted therapy can be the primary novel treatment for PTSD that happens after a violent or traumatic experience. Antidepressants are currently the one approved medications for PTSD. But fewer than 60 percent of patients reply to this approach, and only 20 to 30 percent of patients are cured, in keeping with a 2009 article within the journal Progress in Neuro-Psychopharmacology and Biological Psychiatry.
“MDMA allows you to access these really deep traumatic memories in a way that doesn't induce anxiety,” Jennifer Mitchell, a UCSF neuroscientist who led the study submitted to the FDA, told the Mercury News in 2022.
Jonathan Lubecky, 46, a retired Army sergeant who participated in clinical trials and lives in Washington, D.C., said MDMA relieved his symptoms. After a 12 months in Iraq, he suffered from severe post-traumatic stress disorder and repeatedly woke up from nightmares drenched in sweat.
The drug has long languished within the shadows of the counterculture. It is currently classified by the Drug Enforcement Agency as a Schedule 1 drug, like heroin, for which there’s “no currently recognized medical use and a high potential for abuse.”
MDMA research received the green light from the FDA in 2017 and was granted “breakthrough therapy” status, allowing experiments to speed up.
In rigorously controlled studies, it has shown promising effects in relieving symptoms of post-traumatic stress disorder when combined with talk therapy. It will not be a classic hallucinogen like LSD; as an alternative, it triggers feelings of intimacy, connection and euphoria.
In the UCSF study funded by Lykos, patients received MDMA as a part of an intensive four-month talk therapy that included greater than a dozen sessions, three of which involved taking the drug. At the top of 1 study, 86 percent of individuals within the MDMA group were higher and 71 percent now not met the standards for a PTSD diagnosis. Of those taking the placebo, 69 percent were higher and 48 percent now not met the standards for a PTSD diagnosis.
But FDA staff evaluation found that the study was flawed since it was not truly “blinded.” Participants and therapists could work out who was receiving MDMA and who was receiving a placebo.
If the product had been approved, Lykos would have had exclusive marketing rights for five years. Under the leadership of CEO Amy Emerson, who previously worked at pharmaceutical giants Novartis and Chiron, the corporate raised around $150 million and grew to over 120 employees.
“The FDA's request for another study is deeply disappointing,” Emerson said in an announcement Friday. “We are heartbroken for the millions of military veterans, first responders, victims of sexual and domestic abuse, and countless others who suffer from PTSD and may now face additional years without access to new treatment options.”
In the approaching years, more psychedelics are expected to be reviewed by the FDA for therapeutic purposes.
Originally published:
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