FDA Approved Psilocybin Investigational New Drug Application

Psilocybin has become increasingly popular in pharmaceutical research to treat multiple neurological and mental health conditions. The FDA recently approved an investigational new drug (IND) application from Xpira Pharmaceuticals. This application will allow the company to conduct clinical trial testing to determine how psilocybin-assisted therapy impacts the treatment of anorexia nervosa (AN).

Among many psychiatric conditions, AN is one of the most fatal. Currently, there are no approved treatments for AN. According to the press statement from Xpira, AN does not have any pharmacologic or psychotherapeutic treatments available.

"Throughout my career as a psychiatrist, I have participated in many high-profile pharmacological trials in AN, all of which failed to meet their objectives," said Allan Kaplan, MD, Xpira's Vice President of Clinical Development, in the press announcement.

With recent advancements in neurobiology, researchers and clinicians at Xpira believe that psilocybin’s mechanism of action may be beneficial for patients suffering from AN. Since the drug is psychedelic and can have intense side effects, the plan is to monitor the usage and combine the treatment with psychotherapy closely.

Eating disorders are complex conditions that impact mental health as well as physical health. Often eating disorders are concurrent with other psychiatric conditions. Understanding how to treat these conditions can significantly improve quality of life.

Beyond the potential for developing a treatment regimen for AN, this research may help clinicians gain a better understanding of how psilocybin works. Investigational use of psilocybin may teach healthcare professionals how they can develop additional clinical trials to test its efficacy in treating other psychological or neurological conditions.

“AN could be potentially successfully treated with psilocybin when utilized and overseen properly within the parameters of psychedelic-assisted psychotherapy. With clear clinical endpoints and a robust study design, and taking into full account the vulnerability of AN patients, we hope to move closer to a treatment that will both improve the prognosis of sufferers and bring us closer to a more complete understanding of this pervasive and difficult-to-treat condition," concluded Kaplan in the press statement.