Psilocybin, the hallucinogenic found in magic mushrooms, has been linked to treatment of depression and now America’s Food and Drug Administration is trying to fast-track approval of the banned substance by labeling it a ‘breakthrough therapy’ for major depressive disorder.
“Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s),” says the FDA website.
This is the second time in the last 12 months that the FDA has designated breakthrough therapy status to psilocybin after clinical trials for treatment-resistant depression, according to New Atlas.
That trial, being conducted by a company called Compass Pathways, has now entered its second phase and spans several countries across Europe alongside the US.
Now the FDA has granted the status to a second US-only trial being conducted across seven sites by a non-profit company called the Usona Institute as they look to treat patients with major depressive disorder with a single psilocybin dosage.
“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials,” Usona Clinical and Translational Research Director Charles Raison was quoted as saying in a statement issued by the company. “What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies. Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”
New Atlas claims around a third of all treatments granted Breakthrough Therapy end up being given market approval so the chances of doctors prescribing psilocybin for MDD are still slim in the near future but news that the hallucinogenic substance provides ‘substantial improvement over available therapy’ offers hope.