MDMA Just Received Early But Limited FDA Approval
The FDA granted MDMA an Expanded Access designation, meaning a small number of US clinics may now administer the drug for treatment-resistant forms of depression and PTSD.
Published on January 21, 2020

Molly is officially medicine, but don’t break out the glow sticks just yet.

On Friday, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the FDA granted Expanded Access designation to MDMA, a Schedule I drug often taken by festival goers and nightclubbers. The FDA’s Expanded Access or “compassionate use” program allows terminally ill patients or those with difficult-to-treat conditions to legally use experimental drugs that haven’t yet received full FDA approval

“We commend [the] FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” said MAPS’s founder, Rick Doblin, in a press release. “We are delighted to begin generating real-world evidence about this potential new treatment.”

However, patients looking to sign up for MDMA treatment will need to get in line. According to MAPS, the FDA has only approved 50 patients across 10 US clinics under the Expanded Access program. After the first 35 patients undergo MDMA-assisted psychotherapy, MAPS can potentially increase the total number of approved patients. 

Furthermore, only patients with “moderate to severe treatment-resistant PTSD” can qualify — so that means they’ll need plenty of medical documentation to back-up their treatment-resistant claims. And they’ll need $15,000 for the treatment, too.

“The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” said Michael Mithoefer, MD, the Acting Medical Director for MAPS’s Public Benefit Corporation. “Combining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche.”

For decades, MAPS has funded, designed, and overseen clinical studies for MDMA as a potential treatment for PTSD. Currently, there is no cure for PTSD. Conventional treatments typically include years of talk therapies and an addictive cocktail of tranquilizers, opioids, and mood stabilizers to control its symptoms. 

But recent studies show that in as little as two MDMA-assisted therapy sessions, some patients no longer qualify for full-blown PTSD, which has been practically unheard of modern medicine — until now. The drug’s effects can possibly last for years at a time, as well, indicating that patients may not have to continuously undergo MDMA-assisted psychotherapy to receive its benefits.

US researchers recently entered Phase III clinical trials for MDMA, which means the drug is in the final stages before receiving FDA approval and can hit the American market. While the Expanded Access program has so far only softly approved MDMA for treating PTSD, other studies have shown that MDMA can also potentially help with clinical depression; mentally and emotionally coping with death; and can facilitate deep, meaningful, empathic bonding between individuals. Also, MDMA is fucking awesome for chemsex (or so we’ve heard), but that application will likely never receive FDA approval. 

While the data suggests that MDMA is perfectly safe if administered in a controlled, infrequent manner, heavy and frequent use can cause irreversible skeletal-muscular damage. Meanwhile, cannabis flower, which is relatively non-toxic, still hasn’t even entered into Phase I clinical trials in the US. 

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Randy Robinson
Based in Denver, Randy studied cannabinoid science while getting a degree in molecular biology at the University of Colorado. When not writing about cannabis, science, politics, or LGBT issues, they can be found exploring nature somewhere in the Rocky Mountains. Catch Randy on Twitter and Instagram @randieseljay
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