Who would have thought that MDMA could beat cannabis as the first federally illegal substance to become a prescription medication in the new decade?
Despite the gains made by the cannabis legalization movement (11 states have legalized cannabis for adult use, while medical marijuana is legal in 22), the plant is still a long way from gaining FDA approval as a prescription medication. In fact, MDMA is poised to receive approval before cannabis, according to Brad Burge, director of strategic communications for the Multidisciplinary Association for Psychedelic Studies (MAPS).
“We’re going to have prescription-drug approval for psychedelics like MDMA before we have FDA-approval for cannabis,” he tells DoubleBlind.
Right now, cannabis and MDMA are both classified as Schedule I drugs under the Controlled Substances Act (CSA), which means the federal government defines them as dangerous, with a high potential for abuse and no accepted medical use. But federal lawmakers are facing intense pressure to update the CSA in light of mounting evidence that supports the medicinal value of cannabis as well as psychedelics. When the feds finally do take action, says Burge, they’ll likely sanction MDMA before cannabis.
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Burge admits his prediction might seem “surprising and counter-intuitive” given that no states have legalized MDMA as of yet. But the cannabis movement’s progress in individual jurisdictions has yet to translate as success on the federal level, where cannabis research is lagging behind studies of psychedelics. Last year, several bills were introduced to help advance federal cannabis research (including the Medical Marijuana Research Act of 2019 and the Responsibly Addressing the Marijuana Policy Gap Act), but Congress has not acted on them yet. (Meanwhile, the MORE Act, which would legalize cannabis for adult use, is still under Congressional consideration, but would not render cannabis an FDA-approved medicine.)
“Cannabis policy reform has been advanced primarily through political advocacy as well as smaller, spread-out studies instead of federal research,” says Burge. “There is more federal research on MDMA and other psychedelic substances. The only federal clinical trial of smoked cannabis was the one conducted in Arizona by MAPS for post-traumatic stress disorder (PTSD), the data from which is currently undergoing review. We’ve been able to move much further ahead with psychedelics.”
In fact, MAPS is currently undertaking Phase 3 trials for MDMA as a treatment for PTSD. Phase 3 is the final step that a drug must undergo prior to becoming an FDA-approved, prescription medication. Meanwhile, MAPS’ cannabis trials, led by Dr. Sue Sisley at the Scottsdale Research Institute, have completed Phase 2, but have yet to move onto Phase 3 because the previous results are being reviewed and the cannabis that’s currently being used for federal research is not acceptable for a Phase 3 study.
Whereas MDMA only has to clear one more major obstacle before it’s officially recognized as medicine, Burge notes, “we’re nowhere near Phase 3 trials for smoked cannabis for a specific indication.”
Sceptics might scoff at the idea that the FDA would actually approve a substance that is still seen as a party drug, but Burge is confident that the Phase 3 trials will succeed, based on a special arrangement that MAPS made with federal regulators. Prior to the start of the Phase 3 trials, the FDA signed a Special Protocol Assessment (SPA), which means that, as long as the trials meet a set of agreed upon benchmarks, MDMA will be automatically approved.
“We are very confident in the Phase 3 trials, and they are very confident since they signed that agreement,” Burge says. Moreover, the FDA has granted MDMA “breakthrough therapy” status, a designation intended to expedite the development of drugs that could be potentially life-saving, and fast-track them to market. (In the case of MDMA, this means saving a PTSD patient from suicide.)
MAPS’ MDMA Phase 3 trials are expected to wrap up by the middle of 2021. The results will then be submitted to the FDA for approval, which should happen by the end of 2021 or 2022, according to Burge.
But that doesn’t mean people will be able to fill prescriptions for MDMA at Walgreens and take it home with them. The Phase 3 trials are for MDMA-assisted psychotherapy. If successful, then the FDA will only allow patients to use MDMA in a clinical setting under the supervision of a doctor. That strict requirement will likely remain in effect for the foreseeable future.
“Adult use for psychedelics outside of therapy will have to come with public education and public safety policy, so that’s going to be several years down the road,” Burge says. “And by ‘several’ I mean approximately 10 to 20 years.”
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