The US Food and Drug Administration has granted breakthrough therapy designation to Usona’s program. This means the clinical trials are showing psilocybin works substantially better than conventional MDD drugs.
When a drug receives a breakthrough therapy designation, the FDA works to expedite the development and review of the drug so it can get to patients as soon as possible. The designation is considered for medications used to treat serious or life-threatening conditions. The FDA grants or denies the request for breakthrough therapy designation within 60 days of receiving the supporting clinical evidence from the drug sponsor.