Psychedelics

The panelists expressed concerns about clinical trial data and concluded that the benefits do not outweigh the risks, but the FDA does not have to follow their recommendation.

This is the first FDA advisory committee meeting that will review a potential new posttraumatic stress disorder treatment in 25 years.

Sa’ed Al-Olimat, PharmD, co-founder of the Psychedelic Pharmacists Association, discussed the future of psychedelic medicines and the unique ethical challenges they present.

However, psychedelic medicine has a variety of barriers, including historical perception, access challenges, legal obstacles, and ethical questions.

Despite being a Schedule I drug, cannabis is increasingly used in oncology for symptom management, although data remains limited.

MDMA-assisted therapy and psilocybin currently lead the way with potential approvals by the FDA.

Psychedelic medicines such as psilocybin, MDMA, ketamine, and LSD have been shown to have a significant impact on conditions such as major depressive disorder, generalized anxiety disorder, and post-traumatic stress disorder in clinical trials.

Sa'ed Al-Olimat, PharmD, also discussed the potentially groundbreaking shift for MDMA expected later in 2024.

LSD d-tartrate (MM-120) showed rapid improvements in patients with generalized anxiety disorder by day 2 of the study.

At 4 months, 75% of participants achieved remission and no longer showed signs of depression symptoms in a phase 2 clinical trial.

If clinical trials continue to show that psychedelics offer safe and long-lasting results, then psychedelic-assisted therapy could flourish as a treatment in the mental health space.

Many psychedelics being studied for clinical use are not "magic mushrooms", rather clinical drugs formulated using good manufacturing practice standards.

Investigators continue to conduct regulated and controlled clinical trials to build compelling, high-quality evidence on their therapeutic potential.

If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.

The co-founders of PPA discuss the importance of advocacy work at this point in the development of the psychedelic medicine industry to help cement pharmacist’s role in the continuum of care.

The investigators note that psilocybin’s effectiveness in treating depressive symptoms and the positive reception among patients with cancer are encouraging continued research.

By combining the administration of psychedelic compounds with therapeutic support, ketamine-assisted therapy is proving remarkable efficacy in treating mental health conditions.

Jordan Sloshower, MD, MSc, describes his experience working in several clinical trials investigating psilocybin-assisted therapy.

In the clinical setting, psychedelic medicine has promise as a safe and efficacious treatment for PTSD, TBIs, and other mental health issues.

Ketamine topical cream may alleviate symptoms of PTSD without causing the adverse effects and abuse potential often associated with other forms of ketamine administration.

California is possibly on the verge of signing a bill that would decriminalize the personal possession of natural psychedelics for those aged 21 years and older.

Although it has some daunting adverse effects, Glenn Short, PhD, said ibogaine offers unique biological and therapeutic effects.

KET01 could successfully treat treatment-resistant depression while limiting adverse effects in the home environment, according to the study.

The daily oral formulation of ketamine, KET01, has the potential to greatly improve the standard treatment practices for treatment-resistant depression, according to investigators.