As Florida opens new paths to psychedelic therapy, treatment must be available to all | Opinion

Mental illnesses like depression and anxiety affect nearly 1 in 5 adults in the United States each year, including over 2.9 million adults in Florida alone. While innovation in the psychiatric treatment space has been largely stagnant over the past decade, the promise of novel psychedelic therapies may offer a new hope to people living with these conditions.

Psychedelic and empathogenic compounds have only recently gained traction in a medical setting, but MDMA was originally invented in 1912, and psilocybin, the active compound in “magic mushrooms,” is thought to have been around for thousands of years.

The FDA has now granted breakthrough therapy designation to several psychedelic-based therapies: two psilocybin-based therapies for the treatment of depression, LSD for anxiety, and MDMA for post-traumatic stress disorder (PTSD.) Florida already has begun preparing for the advent of psychedelic-based therapies, as many psychedelic drug development companies have relocated here alongside the already high concentration of entrepreneurs and investment funds advancing the psychedelic therapeutic ecosystem.

However, FDA clearance of these psychedelic therapeutics is only one part of making them accessible to patients. One of the main challenges to widespread access and adoption is the monitored hallucinogenic experience (the “trip”), which can last an average of six hours for psilocybin and up to 12 hours for LSD.

Because these drugs must be administered under the supervision of a physician in a treatment center, psychedelic therapy will no doubt be very costly, anticipated to range from $3,000 to $25,000-plus for a single course of treatment. This cost may severely limit coverage and, thus, access for patients who cannot afford to pay for these lengthy supervised sessions.

Roughly 14.4% of the population of the Miami-Dade area is currently living under the poverty line, a figure about 10% higher than the average rate across Florida and about 20% higher than the average rate across the U.S. This population is nearly 2.5 times more likely to suffer from mental health conditions like depression and anxiety and, at the same time, unable to pay for these types of psychedelic sessions that may offer effective treatment.

One solution to help address barriers to access is a scientific approach to remove the trip component from psychedelic compounds. While psychedelics act on a wide variety of receptors in the brain, only the serotonin 2A receptor is responsible for the trip. It was recently shown in a human study that combining a psychedelic with a selective serotonin 2A receptor blocker eliminated the trip but still allowed the psychedelic to change the functional connectivity of the brain. This approach is now under development as a potential take-home medication that would not require monitoring in a clinical setting. Removing the trip may solve the unique logistical problems posed by these therapies and represent a cost-effective solution to ensure better reimbursement and broader access.

Another solution could be the FDA’s accelerated 505(b)(2) pathway, which permits pre-existing data to be included in an application. The prices of new therapeutics are often prohibitively high until generics enter the market many years later. Fortunately, the first few psychedelics nearing approval (psilocybin, MDMA, LSD) are older compounds, making them eligible for 505(b)(2). Miami-based Terran Biosciences is preparing to leverage this pathway to bring additional forms of these psychedelics to market only five years after their initial approval, significantly broadening therapeutic options, access, and affordability for South Florida and across the US.

Psychedelics may indeed represent a paradigm shift in the treatment of mental illness, and Florida is leading the charge in preparing for the first approvals. However, given FDA approval is only half the challenge. Significant steps must be pursued to address these challenges and ensure access to these potentially life-changing therapeutics.

Dr. Sam Clark is founder and CEO of Terran Biosciences, a platform to transform the approach to therapeutics in neuropsychiatry that has one of the largest psychedelic development programs in the industry.