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FDA Approves Expanded Access Program for MDMA Research

Ecstasy tablets Date: 19 January 2006, 08:48:36 Source: DEA, US Author: DEA

“From the opioid crisis to psilocybin’s potential w/ PTSD, it’s well past time we take drug use out of criminal consideration + into medical consideration.”

The United States Food and Drug Administration approved further research for MDMA treatment to treat post-traumatic stress disorder (PTSD). MDMA, often referred to as ecstasy or molly, is 3,4-Methyl​enedioxy​methamphetamine, a psychedelic drug.

The Multidisciplinary Association for Psychedelic Studies (MAPS) organization has researched and advocated for the use of psychedelic therapy and medical marijuana since 1986. Only recently, however, has the nonprofit made legal headway. In August 2017, the FDA granted the medical field Breakthrough Therapy Designation, thereby fast-tracking its research and development.

Phase 3 Begins

On Dec. 20, the government agency notified MAPS that it had approved the organization’s application for the Expanded Access program, CBS Baltimore reported. The expansion begins Phase 3 of MAPS’ research, which is expected to conclude in 2021 with an FDA approval for the general public coming as soon as 2022. 

Twenty-six PTSD patients participated in the previous trial and after two sessions, 68% exhibited no PTSD symptoms, Miltary.com reported. The mental disorder affects 7 to 8% of the US population and 11 to 20% of veterans since who have served since 2001, according to the Department of Veteran Affairs.

Phase 3 of the clinical trial will involve 50 patients, who must pay for the treatment on their own. As of Jan. 20, MAPS had already received 120 applications from potential participants.

MDMA Saves Army Veteran 

MDMA has already received glowing reviews from those who have tried it, including retired Sgt. Jonathan Lubecky, Iraq War veteran. Lubecky struggled with PTSD since he left the Army in 2009. Several different types of therapy failed to alleviate his symptoms, nor did antidepressants. 

Lubecky tried to commit suicide five times before he enrolled in the MDMA trial in 2014. The psychedelic session consisted of an eight-hour trip designed to open a patient’s mind to the therapist for “intensive psychotherapy.” For Lubecky, three sessions is all it took. He is now symptom-free of PTSD.

MDMA propels a patient into a euphoric state while blocking fear receptors in the brain. 

“The MDMA puts the mind, body and spirit in a place it needs to be in order to heal,” Lubecky said. “t’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face. That’s the best way I’ve been able to describe it.”

PTSD, commonly caused by brain injuries, has perplexed medical doctors and the military as the number of cases continue to rise. Since the War on Terror began, the Pentagon has renewed his focus on studying brain ailments in an attempt to curb fallout from PTSD cases, such as suicide, for example. 

“We’ve all been told this is a chronic, lifelong mental illness, that our symptoms can be addressed but we can’t make it go away,” Lubecky said. “MAPS and this MDMA therapy have shown that we can heal it.”

MDMA may offer advantages where other types of drugs fall short. Serotonin-boosting antidepressants can take several months before a patient feels relief and often prescriptions have to be tweaked. Adults taking antidepressants are also 2.5 times more likely to commit suicide because the drugs restore motivation and energy, but do not remove the symptoms behind depression, Fortune reported.

The mental health pharmaceutical industry is booming as a result of a trove of disorders, including PTSD, depression, and anxiety. Sales in 2017 exceeded $14 billion for antidepressants alone. Compared to antidepressants, data from MDMA and Psilocybin—the psychedelic ingredient in magic mushrooms—studies has proven psychedelics are considerably more effective at treating PTSD.

Clinical trials of Psilocybin have shown a reduction and anxiety and depression in cancer patients.

AOC’s Failed Amendment in Congress

In June 2019, Rep. Alexandria Ocasio-Cortez, D.-N.Y., proposed an amendment to allocation legislation that would have removed restrictions on federal funding for Schedule I drugs, which include marijuana and MDMA. 

“From the opioid crisis to psilocybin’s potential w/ PTSD, it’s well past time we take drug use out of criminal consideration + into medical consideration,” tweeted the New York Representative. “That begins with research. I’m proud to introduce an amendment that helps scientists do their jobs.”

The bill was cosponsored by Reps. Lou Correa, D.-N,Y., Ro Khanna, D.-CA., and Matt Gaetz, R.-Fla. The House of Representatives voted against its passage in a 91 to 331 vote, however.

Rep. Andy Harris, R.-MD, said the amendment “sends a bad signal” about Schedule I drugs as a whole. 

“Do we want the federal government telling our families and our children, take this, it’s good for you?” he asked. “Maybe it is. I sure don’t think it is. I certainly don’t want my kids taking it and I don’t want the government promoting it.”

Although Congress is not providing funding for MDMA or marijuana research in the near future, MAPS is continuing forward with Phase 3 of its trials. At the conclusion, it will present its data to the FDA, which will then make a determination on whether it is a viable option for the general public. 

Certainly it will be a different kind of drug, if offered on a wide scale. A patient would like not be able to purchase it from their local pharmacy and consume it at home. Not only is that dangerous, but the success of MDMA’s clinical trials was dependent upon simultaneous therapy sessions during its usage.

Daniel Davis

Daniel Davis is Managing Editor for The Osage County Herald-Chronicle in Kansas and also covers International news for Inside Over, a Milan-based global affairs publication. He graduated in 2015 with a bachelor’s degree in political science. Outside of writing, he enjoys photography and one day hopes to return to video production. Learn more about him at his website danieldavis.la.

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