Drug Discovery and Development

FDA rejection of MDMA and journal retractions jolt psychedelic therapy research

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MAPSIn a double-blow to psychedelic therapy, the FDA has rejected an application for MDMA-assisted treatment of PTSD, while a prominent medical journal has retracted three key papers on the subject. The agency, which had granted Breakthrough Therapy Designation to MDMA in 2017, signaled it may be open to changing its mind if presented with data from an additional Phase 3 study.

FDA issues complete response letter for MDMA-assisted therapy. Several psychedelic stocks were down after FDA announced that it would issue a complete response letter (CRL) for MDMA-assisted therapy as a PTSD treatment, rejecting the efforts to legitimize the drug for post-traumatic stress disorder — at least for now.

Journal retractions add to woes

Compounding the setback for MDMA-assisted therapy, the medical journal Psychopharmacology retracted three papers related to MDMA use in PTSD treatment on August 12. In a post announcing the decision, the journal cited protocol violations amounting to unethical conduct at one study site.

Here’s a high-level overview of the varying perspectives from the June 4 advisory committee meeting.

Filed Under: clinical trials, Psychiatric/psychotropic drugs
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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