Drug Development

Investigators prep PhIII in effort to move MDMA (you know it as ecstasy) off the street and into use for PTSD

Over the past few years there has been a growing push to study the efficacy of illicit drugs for a range of neuropsychiatric conditions. And now a group of investigators are reportedly prepping a Phase III trial of MDMA, better known on the street as ecstasy, for post traumatic-stress disorder.

The Multidisciplinary Association for Psychedelic Studies is undertaking the study, according to The New York Times, which did an in-depth feature on the drug and its slow progress in the clinic. MAPS, a nonprofit fueled by donations, has been advocating for the clinical use of a range of psychedelics like MDMA and LSD, as well as marijuana, but only after a rigorous scientific review. And it can cite Phase II data that indicate MDMA can end PTSD symptoms that afflict a large percentage of patients.

They’re not alone in this approach.

David Nutt in the UK — former drugs adviser to the government — has been advocating the same position, often quite controversially, with a new study out earlier this year that looks at the illuminating impact of LSD on the brain. Academics have repeatedly looked at the use of ketamine, or Special K, for depression and suicide. Last summer Robert Malenka, a psychiatrist and neuroscientist at Stanford University, noted that scientists still have no idea of all the pathways that MDMA takes. But it is known that the Schedule 1 drug elicits very strong feelings of empathy, which may make it particularly effective in treating conditions like PTSD.

“Drugs like MDMA should be the object of rigorous scientific study, and should not necessarily be demonized,” Malenka noted recently. But not everyone is happy with the idea.

“It sends the message that this drug will help you solve your problems, when often it just creates problems,” Swansea University’s Andrew Parrott told The Times. “This is a messy drug we know can do damage.”

MAPS may be in a better situation to address that concern after its Phase III. There are no specific timelines in The New York Times piece, but the writer says that the investigators are seeking a breakthrough drug designation to speed a regulatory review. Regulators, though, have a long track record of remaining extraordinarily cautious in handling controlled substances. The group tells The Times that they should have a product ready by 2021.

Five years to finish a Phase III with 230 patients and a BTD fits no known development outline I’m familiar with, unless they’re planning a series of studies to convince skeptics. In this field, though, researchers are blazing a completely unique, and very difficult, clinical trail.


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RAPS Regulatory Convergence 2017