S.J.B.
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FDA Recognizes Psilocybin As 'Breakthrough Therapy' for Depression
Jacob Sullum
Reason
October 25th, 2018
Read the full story here.
Jacob Sullum
Reason
October 25th, 2018
The only reference to psilocybin on the Food and Drug Administration's website appears in the agency's Bad Bug Book: Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins, where the psychedelic compound is described as a "neurotoxin" found in mushrooms. But according to the FDA, psilocybin is also a "breakthrough therapy" for major depression.
That designation, which the company seeking approval of psilocybin as a medicine announced this week, means "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies." Based on that evidence, the FDA agrees to "expedite the development and review of such drug."
The FDA's dueling portrayals of psilocybin as a scary fungal neurotoxin and a promising treatment for depression are part of a broader story about forbidden drugs, including MDMA, marijuana, and LSD, whose benefits scientists are once again studying with government approval after decades of neglect. The rehabilitation of these substances, which may ultimately make them available as prescription drugs, is a far cry from the pharmacological freedom that libertarians favor. But it represents a welcome return to empiricism in an area of public policy long driven by irrational prejudice.
A preliminary 2016 study sponsored by COMPASS Pathways, a British life sciences company, found big improvements in a dozen subjects with "treatment-resistant major depression" who received psilocybin in a "supportive setting." After one week, their mean score on the Quick Inventory of Depressive Symptoms, which has a scale ranging from 0 to 27, had fallen from 19.2 to 7.4, a 61 percent drop. Most of that progress was still apparent at three months, when the mean score was 10, or 48 percent lower than the baseline. Last August the FDA approved COMPASS Pathways' plan for Phase 2 clinical trials, which will involve 216 subjects at 12 to 15 research sites in Europe and North America.
Read the full story here.