FDA on Board with Psilocybin as a “BreakThrough Therapy”
As the world is plagued by a pandemic, unemployment rates have skyrocketed, and people are forced to end their social life as they know it, millions are now struggling with Major Depressive Disorder or MDD and crippling anxiety disorders which can lead to problems with addiction or even suicide.
The FDA is finally taking a newfound stance when it comes to breakthrough medicine like psilocybin mushrooms and MDMA.
A breakthrough therapy is designated by the FDA for any drug or substance that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant outcome over traditional and currently available therapies. For the past 18 months, many companies are flourishing in the newly awakened entheogenic plant industry and the FDA is helping to speed up the process of researching and approving psilocybin, MDMA, and Ketamine for breakthrough treatments in patients with Depression, Anxiety, PTSD, and even addiction.
For the second time in the past year, the U.S. Food and Drug Administration has declared psilocybin a "Breakthrough Therapy Treatment" and companies have entered phase 3 clinical trials, designated to MDMA and psilocybin assisted psychotherapy and integration. This declaration by the FDA is meant to accelerate the typically long and slow process of drug development and research. It is typically requested by a drug company and granted only when preliminary evidence suggests the drug may be an enormous improvement over already available therapy, according to the FDA. Last year, the FDA granted "breakthrough therapy" status to psilocybin therapy in the clinical trials run by the company Compass Pathways, which are looking into psilocybin's potential to treat severe treatment-resistant depression or depression in patients who have not improved after undergoing two different antidepressant treatments.
The FDA has granted another "breakthrough therapy" status to psychedelic treatment, for a U.S.-based clinical trial conducted by a nonprofit company, Usona Institute. A single dose of psilocybin within a safe setting and an assisted psychotherapist focusing on post-integration, could profoundly impact the brain and have long-lasting impacts after wiping away depressive symptoms. Around one in three treatments previously given a Breakthrough Therapy status by the FDA have moved on to get market approval. This isn't the first time that a psychedelic has been researched for its potential in treating depression. In March of 2020, the FDA approved a nasal spray depression treatment for treatment-resistant patients based on Esketamine, a substance related to ketamine. The re-emergence of therapeutic uses for mind-altering, Entheogenic psychedelic drugs has brought the field of mental health to a new frontier in research, product development, and advocates making long-needed policy changes. In the past two decades, dozens of clinical trials investigating therapeutic applications of psychedelics—including MDMA, psilocybin, and ketamine have shown promising results in the treatment of trauma-related disorders, End of life Anxiety, previously untreated forms of addiction, and many more emotional and behavioral issues. These substances have also garnered preliminary support from the Food and Drug Administration, which has fast-tracked their development. As the field of psychedelic science continues to grow, a serious consideration of these “Breakthrough” Treatments should be decriminalized and made available to all patients in need of these amazing entheogenic substances.
