WASHINGTON (AP) — Federal health advisers MDMA, the mind-altering club drugAs a treatment for PTSD, Decades of effort Proponents of psychedelics developed the drug in an effort to gain medical approval for its purported benefits.
The Food and Drug Administration convened a panel of outside experts on Tuesday to Latest research on medicinesThis seems to suggest that combining it with talk therapy may help ease post-traumatic stress disorder.
But FDA regulators have questions about the reliability of that data and about MDMA’s safety risks, including heart problems, injury and potential for drug abuse.
An FDA panel is scheduled to vote later Tuesday on whether to recommend the drug for PTSD, which could lead to federal approval later this summer, though the FDA is not required to follow the committee’s recommendation.
If approved, MDMA, also known as ecstasy or Molly, would be the first illegal hallucinogen to break into mainstream medicine. Hallucinogens Series The drugs are expected to be submitted to the FDA within the next few years as part of renewed research and interest in their potential to address hard-to-treat conditions such as depression, addiction and anxiety, including LSD and psilocybin.
Currently, only antidepressants are FDA-approved to treat PTSD, which is closely linked to depression, anxiety and suicidal behavior, and is more common among women and military veterans.
But the FDA’s investigation of MDMA highlights the difficulties of studying and evaluating psychedelic drugs.
“This application is significant and complex,” FDA reviewer Dr. Tiffany R. Falcione said at the start of Tuesday’s meeting.
MDMA induces such an intense psychological experience that nearly all patients in two key studies of the drug were able to guess whether they had received MDMA or a placebo. This is the exact opposite of the objectivity typically required in quality drug studies, where patients cannot tell whether they received the drug being tested.
“This makes it difficult to know how much of the treatment effect is a true benefit and how much is due to expectation bias,” Falchione said.
The FDA plans to question an outside committee about this and several other issues, including uncertainty about how long MDMA’s effects last. About 25 percent of patients dropped out of follow-up studies designed to track long-term outcomes.
FDA regulators are also concerned about safety risks with the drug, and the possibility that patients could harm themselves if the drug’s effects last longer than eight hours. MDMA has also been linked to increased blood pressure.
Because of these risks, the FDA is proposing to place strict restrictions on how and where MDMA could be used if approved. Only specially certified doctors and therapists would be able to prescribe and administer the drug. Patients would have to be registered and followed over time. Medical professionals would also have to be on hand to take patients’ vital signs while they were taking the drug.
A representative for drug company Lycos Therapeutics said Tuesday that he agreed with the precautions and hoped they would speed up the drug’s approval.
“It’s clear that MDMA-assisted therapy would be a welcome addition to the options currently available,” said Dr. Kelly O’Donnell, a psychiatrist at New York University who helped conduct the MDMA study. “I’ve seen firsthand that this treatment can be life-saving for some people.”
Lycos is essentially The nation’s leading psychedelic advocacy groupThe study was funded by the Multidisciplinary Association for Psychedelic Drug Studies (MAPS), a group founded in 1986 to promote the benefits of MDMA and other mind-altering drugs.
In two key studies, patients were given MDMA as part of four months of intensive talk therapy over 12 sessions, but only took the drug three times. After treatment, patients who received MDMA had significantly lower PTSD scores.
MDMA affects two feel-good brain chemicals, serotonin and dopamine, which are thought to enhance the effectiveness of talk therapy, and experts believe the drug can help patients confront past trauma by reducing fear and increasing connection and trust with the therapist.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science Education Media Group. The AP is solely responsible for all content.
