Veterans Affairs preps for potential FDA-approval of MDMA

3 weeks ago 57

A planning document focused on preparing to quickly deploy psychedelics for treating PTSD has reportedly been circulated in the VA.

The U.S. Department of Veterans Affairs is preparing a strategy to deploy of psychedelic treatments for mental health disorders if such therapies receive approval from the FDA, according to a document reviewed by the outlet.

According to a report in The Intercept, a document that outlines the responsibilities of the “Psychedelic Medicine Integrated Project Team” has been circulated within the VA, however, the agency declined to comment on the topic.

The document reportedly includes regular tasks for the team, such as advising the VA Under Secretary for Health Shereef Elnahal and providing “strategic direction for the deployment of psychedelic medicine for mental health treatment in (the Veterans Health Administration).”

FDA hearing on MDMA

This news comes in advance of an FDA advisory committee scheduled for June 4 that includes a public hearing regarding the potential approval of MDMA-assisted therapy for post-traumatic stress disorder (PTSD).

Green Market Report previously wrote: “In a federal notice, the FDA said the Psychopharmacologic Drugs Advisory Committee will discuss the overall benefit-risk profile and potential public health impact of Lykos Therapeutics‘ application for MDMA capsules on June 4. The committee provides nonbinding recommendations to the agency.”

The Veterans Health Administration is the largest integrated health care system in the U.S., with more than 150 medical centers, and one of its current focuses is treating veterans suffering from drug-resistant depression and PTSD. In January, the VA announced it had issued a request for applications for proposals from its network of VA researchers to study the use of certain psychedelic compounds in treating PTSD and depression including MDMA.

Preparing for big demand

The Intercept wrote that on May 10, Elnahal spoke at the Horizons psychedelics conference in New York, saying there was an “unstoppable narrative” in support of legalizing psychedelic medicine.

“The VA must be prepared for the ‘overwhelming demand’ upon the approval of MDMA-assisted therapy, which could come as soon as August,” Elnahal said, as reported by the outlet.

“The reason I’m here is that the data and results, the stories that I have heard from veterans who have gone through these studies, these therapies, speak for themselves,” Elnahal said. “The evidence-based therapies that we have, while they help, pale in comparison if we are able to replicate the scale seen in the preliminary results we have seen in psychedelics, especially MDMA for PTSD, and increasingly psilocybin for treatment-resistant depression.”

Treatment realities

While MDMA, which is also known as ecstasy, has been a popular nightclub recreational drug, administering the drug under more formal procedures requires planning. Patients would receive a controlled dose that could last for hours, and the process requires professional supervision. This would require a physical space to accommodate long treatments and professionals to oversee the treatments.

This is why the VA is trying to prepare in advance to have the infrastructure ready to go if patient demand is strong.

The FDA has noted that midomafetamine (MDMA) capsules have not been approved by any regulatory agency. Also, the safety and efficacy of the drug have not yet been established for the treatment of PTSD.

Read Entire Article