WASHINGTON (AP) — Federal health regulators are questioning the safety and evidence behind the first bid to use MDMA, the mind-altering club drug, as a treatment for PTSD, part of a decadeslong effort by advocates to move psychedelic drugs into the medical mainstream.
The Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA — currently illegal under federal law — becomes the first drug of its kind to win U.S. approval as a medication. The experts will discuss the quality of the evidence and safety concerns Tuesday, including MDMA's potential for abuse, before taking a nonbinding vote on the drug's overall benefits and risks. The FDA will make the final decision, likely in August.
In their assessment, FDA scientists said that patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms,." But they also called the research “challenging to interpret,” and questioned how long the benefits might last. They said it’s difficult to know how much of the improvement came from MDMA versus simply undergoing intensive therapy, and also raised several safety concerns, including MDMA's potential to cause heart problems.
Post-traumatic stress disorder is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans. Currently antidepressants are the only FDA-approved drugs for the condition.
If approved, MDMA would be reclassified as a prescription medicine and made available to specially certified doctors and therapists. Currently the drug is in the same ultra-restrictive category as heroin and other substances the federal government deems prone to abuse and devoid of any medical use.
MDMA, also known as ecstasy or molly, is the first in a series of psychedelics that are expected to be reviewed by the FDA in coming years. It’s part of a resurgence of research into the potential of psychedelics for hard-to-treat conditions like depression, addiction and anxiety. MDMA's main effect is triggering feelings of intimacy, connection and euphoria.
Companies are studying MDMA, psilocybin, LSD and other mind-expanding drugs for numerous mental health problems.
Until recently, psychedelic research was mainly funded by a handful of nonprofit advocacy groups, including Multidisciplinary Association for Psychedelic Studies, or MAPS. The company seeking approval for MDMA, Lykos Therapeutics, is essentially a corporate spinoff of MAPS, which conducted all the studies submitted for FDA review.
In two MAPS studies, patients received MDMA as part of an intensive, four-month course of talk therapy lasting more than a dozen sessions, only three of which involved taking the drug. The drug is thought to help patients come to terms with their trauma and let go of disturbing thoughts and memories.
The group studied its approach in 195 adults with moderate-to-severe PTSD who were randomly assigned to undergo the therapy with MDMA or with a dummy pill. Following treatment, patients who received MDMA had significantly lower PTSD scores and were more likely to be in remission.
But FDA reviewers noted that the vast majority of patients correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the so-called “blinded” objectivity considered essential for high-quality drug research. The agency also questioned how long the drug's benefits might last. MAPS tracked some patients for up to two years, but reviewers noted that about a quarter of patients quickly dropped out of the follow-up study, limiting the usefulness of the results.
The most common side effects of MDMA included headache, nausea, muscle tightness and decreased appetite. More serious issues included heart palpitations and elevated blood pressure, which FDA reviewers said had the “potential to trigger” life-threatening heart problems.
They also raised concerns about the potential for patients to abuse MDMA, which functions similarly to amphetamines and other stimulants.
While MDMA would be a first-of-a-kind approval, U.S. doctors and the FDA itself have already laid some of the groundwork for working with drugs that can cause intense, psychological experiences.
Hundreds of clinics across the U.S. already offer ketamine — the powerful anesthetic sometimes used as a party drug — to treat a host of ailments, including depression, anxiety, chronic pain and PTSD. The FDA has only formally approved the drug for use during surgery, but its availability allows doctors to prescribe it “off-label” for various mental and physical ailments.
In 2019, the FDA approved Johnson & Johnson’s proprietary form of the drug, Spravato, a nasal spray that treats severe depression. Similar to ketamine, the drug is offered at doctor’s offices and clinics where patients usually spend several hours reclining in a chair.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
This photo provided by the Center for Psychedelic Therapy Research shows a Yehuda Lab MDMA-assisted therapy treatment room at the James J. Peters Department of Veterans Affairs Medical Center in the Bronx borough of New York. (OH Prema, Center for Psychedelic Therapy Research via AP)
ATLANTA (AP) — President Joe Biden and his Republican rival, Donald Trump, were set to face off Thursday evening for a debate that offered an unparalleled opportunity for the two candidates to try to reshape the presidential race.
Biden, the Democratic incumbent, will have the chance to reassure voters that, at 81, he’s capable of guiding the U.S. through a range of challenges. The 78-year-old Trump, meanwhile, may use the moment to try to move past his felony conviction in New York and convince an audience of tens of millions that he’s temperamentally suited to return to the Oval Office.
Biden and Trump entered the night facing stiff headwinds, including a public weary of the tumult of partisan politics and broadly dissatisfied with both, according to polling. But the debate was likely to highlight how they have sharply different visions on virtually every core issue — abortion, the economy and foreign policy — and deep hostility toward each other.
The current president and his predecessor haven’t spoken since their last debate weeks before the 2020 presidential election. Trump skipped Biden’s inauguration after leading an unprecedented and unsuccessful effort to overturn his loss that culminated in the Jan. 6 Capitol insurrection by his supporters.
Trump has promised sweeping plans to remake the U.S. government if he returns to the White House and Biden argues that his opponent would pose an existential threat to the nation’s democracy.
Thursday’s broadcast on CNN, moderated by anchors Jake Tapper and Dana Bash, will be the earliest general election debate in history. It’s the first-ever televised general election presidential debate hosted by a single news outlet after both campaigns ditched the bipartisan Commission on Presidential Debates, which had organized every matchup since 1988.
Aiming to avoid a repeat of their chaotic 2020 matchups, Biden insisted — and Trump agreed — to hold the debate without an audience and to allow the network to mute the candidates’ microphones when it is not their turn to speak. There will be two commercial breaks, another departure from modern practice. The candidates have agreed not to consult staff or others while the cameras are off.
Trump and his aides have spent months chronicling what they argue are signs of Biden’s diminished stamina. In recent days, they’ve started to predict Biden will be stronger on Thursday, aiming to raise expectations for the incumbent.
Biden’s team too predicted that he would rise to the occasion, and expressed hope that Trump would be forced to address his positions they believe are anathema to voters.
Heading out of the debate, both Biden and Trump will travel to states they hope to swing their way this fall. Trump is heading to Virginia, a onetime battleground that has shifted toward Democrats in recent years.
Biden is set to jet off to North Carolina, where he is expected to hold the largest-yet rally of his campaign in a state Trump narrowly carried in 2020.
Miller, Price and Weissert reported from Washington.
California Gov. Gavin Newsom speaks during an interview in the spin room before a presidential debate between President Joe Biden and Republican presidential candidate former President Donald Trump in Atlanta, Thursday, June 27, 2024. (AP Photo/John Bazemore)
Corey Lewandowski speaks with reporters in the spin room before a presidential debate between President Joe Biden and Republican presidential candidate former President Donald Trump, hosted by CNN in Atlanta, Thursday, June 27, 2024.(AP Photo/Pablo Martinez Monsivais)
Rep. Byron Donalds, R-Fla., speaks with reporters in the spin room before a presidential debate between President Joe Biden and Republican presidential candidate former President Donald Trump, hosted by CNN in Atlanta, Thursday, June 27, 2024.(AP Photo/Pablo Martinez Monsivais)
Former Atlanta Mayor Andrew Young, from fourth left, and current Atlanta Mayor Andre Dickens, greet President Joe Biden as Biden arrives at Dobbins Air Reserve Base, Thursday, June 27, 2024, in Marietta, Ga., en route to Atlanta to attend the presidential debate. (AP Photo/Evan Vucci)
Georgia Gov. Brian Kemp speaks in the spin room before a presidential debate between President Joe Biden and Republican presidential candidate former President Donald Trump in Atlanta, Thursday, June 27, 2024. (AP Photo/Nathan Ellgren)
Stacey Abrams, former State House of Representatives Minority Leader, former State House of Representatives Minority Leader, center, greets President Joe Biden, right, as he arrives at Dobbins Air Reserve Base, Thursday, June 27, 2024, in Marietta, Ga., en route to Atlanta to attend the presidential debate. (AP Photo/Evan Vucci)
First lady Jill Biden poses for photos with campaign volunteers and supporters at the Virginia Beach Democratic Coordinated Campaign Office on Thursday, June 27, 2024, in Virginia Beach, Va. (AP Photo/John C. Clark)
President Joe Biden, second right, greets supporters, Thursday, June 27, 2024, in Atlanta, Ga., before a presidential debate. (AP Photo/Evan Vucci)
President Joe Biden, second right, greets supporters, Thursday, June 27, 2024, in Atlanta, Ga., before a presidential debate. (AP Photo/Evan Vucci)
President Joe Biden takes a photo with a child as he greets supporters, Thursday, June 27, 2024, in Atlanta, Ga., before a presidential debate. (AP Photo/Evan Vucci)
President Joe Biden, left, greets supporters, Thursday, June 27, 2024, in Atlanta, Ga., before a presidential debate. (AP Photo/Evan Vucci)
FILE - This combination of photos taken in Columbia, S.C. shows former President Donald Trump, left, on Feb. 24, 2024, and President Joe Biden on Jan. 27, 2024. (AP Photo)
