CALIFORNIA, United States, Monday August 28, 2017 – The party drug ecstasy could very well get the nod to be used to treat post-traumatic stress disorder (PTSD).
This after the US Food and Drug Administration (FDA) designated the drug, methylenedioxymethamphetamine (MDMA), a “breakthrough therapy” which may lead to faster approval. The FDA also approved the design of two Multidisciplinary Association for Psychedelic Studies (MAPS)-funded trials for patients with severe PTSD.
“By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD,” the non-profit MAPS said in announcing the FDA’s decision.
PTSD symptoms are triggered by sounds or smells that cause sufferers’ memories to come flooding back. MDMA is thought to dampen this response and allow people to overcome their trauma.
“This is not a big scientific step,” David Nutt, a neuropsychopharmacologist at Imperial College London, was quoted by Science magazine as saying. “It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”
A small U.S. study that first suggested MDMA could help treat PTSD was published in 2011. Since then, researchers in Canada, Israel, and the United States have jointly carried out larger phase II trials funded by MAPS. Their results, which remain unpublished but have been reviewed by the FDA, were very good, says MAPS Executive Director Rick Doblin.
For instance, 107 trial participants had PTSD for an average of 17.8 years, of which 90 were available to be studied 12 months later. Of these 90, 61 no longer had PTSD at the end of the studies.
The biggest hurdle now is raising the approximately US$25 million for the two phase III trials, which together will include between 200 and 300 participants. So far MAPS has raised only US$12.75 million.