Page 7 - IAV Digital Magazine #461

iAV - Antelope Valley Digital Magazine
ShroomFor Improvement: FDA Lists
Psychedelic Drugs as ‘Breakthrough
Therapy’ For Depression
Psychedelic drug researchers can now begin pro- viding psychiatric patients with psilocybin, the active ingredient in magic mush- rooms, as part of their therapy in a landmark approval by the US Food and Drug Administration (FDA).
Psilocybin thera- py for treatment- resistant depres- sion, which cov- ers roughly 50 percent of patients diag- nosed with clini- cal depression in the US, has been granted
a “Breakthrough Therapy designa- tion” by the FDA in a landmark decision, essen- tially admitting that the drug has shown significant potential in early clinical evidence.
“The Breakthrough
Therapy designa- tion is a strong endorsement for the potential of psilocybin thera- py,” Robin Carhart-Harris, head of the Psychedelic Research Group at Imperial College London said in a press release.
The Breakthrough Therapy designa- tion was created in 2012 to expe- dite approvals for drugs that display
a clear advan- tage over a cur- rently available alternatives used to treat serious or life-threatening conditions. While it does not nec- essarily guaran- tee that a drug will make it to market, it does indicate that the administration believes further research would be beneficial.
“This is great news for patients. We are excited to be taking this
work forward with our clinical trial on psilocybin therapy for treat- ment-resistant depression,” said George Goldsmith, the executive chair- man of Compass, in a statement.
Researchers have suggested a rescheduling down to Schedule IV, the category that includes drugs like Xanax and Ambien. For con- text, opioids used
as prescription painkillers are currently consid- ered Schedule II drugs; medically helpful, but with the high potential for abuse.
The FDA has not offered any offi- cial comment on the decision as of yet, citing the confidential sta- tus of Breakthrough Therapy applica- tions.
Psilocybin is cur- rently undergoing clinical trials and if it passes those the FDA will be forced to change the drug’s restric- tive Schedule 1 control status (the most restric- tive under US law, classifying a drug as highly addictive and of no medicinal use).
The most notable reclassification debate in recent times followed
the landmark approval of Epidiolex, the first-ever marijua- na-derived medi- cine. The FDA recommended the reclassifica- tion of marijuana but the DEA resisted, opting instead to reschedule Epidiolex specifi- cally but nothing more.
“We should be clear that psilocy- bin is not without risks of harm, which are greater in recreational than medical set- tings,”says Matthew Johnson from Johns
Hopkins, “but rel- atively speaking, looking at other drugs both legal and illegal, it comes off as being the least harmful in differ- ent surveys and across different countries.”
iAV - Antelope Valley Digital Magazine