What’s next for MDMA

Today, the Food and Drug Administration’s advisory committee will meet to discuss the risks and benefits of MDMA therapy. This notorious party drug, also known as Molly or ecstasy, has been banned in the US for more than three decades. Now it’s poised to become a badly needed therapy for PTSD. In this edition of What’s Next in Tech, find out what you need to know ahead of today’s hearing.?

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Here’s what an approval would mean, and where similar drugs stand in the US.

So, what’s the argument for legitimizing MDMA? Studies suggest the compound can help treat mental-health disorders like PTSD and depression. Lykos, the company that has been developing MDMA as a therapy, looked at efficacy in two clinical trials that included about 200 people with PTSD. Researchers randomly assigned participants to receive psychotherapy with or without MDMA. The group that received MDMA-assisted therapy had a greater reduction in PTSD symptoms. They were also more likely to respond to treatment, to meet the criteria for PTSD remission, and to lose their diagnosis of PTSD.

But some experts question the validity of the results. With substances like MDMA, study participants almost always know whether they’ve received the drug or a placebo. That can skew the results, especially when the participants and therapists strongly believe a drug is going to help. The Institute for Clinical and Economic Review, a nonprofit research organization that evaluates the clinical and economic value of drugs, recently rated the evidence for MDMA-assisted therapy as “insufficient.”

In briefing documents published ahead of today’s meeting, FDA officials write that the question of approving MDMA “presents a number of complex review issues.”

At the meeting, the FDA has asked experts to discuss whether Lykos has demonstrated that MDMA is effective, whether the drug’s effect lasts, and what role psychotherapy plays. The committee will also discuss safety, including the drug’s potential for abuse and the risk posed by the impairment MDMA causes.?

Read the story to learn more about how an approval would shake out, including when people would be able to access it and whether an approval would open the door to legal recreational use of psychedelics.

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Image: Stephanie Arnett & Sarah Rogers/MITTR | Images: NASA, Museum of New Zealand