There has been a recent resurgence in the interest of using psychedelic therapeutic drugs as a potential treatment for mental health issues. The regulatory environment is constantly evolving and has eased some barriers to clinical research. If your organization is considering moving into early clinical development for therapeutic psychedelics, it helps to know a few facts about researching psychedelics to help your organization move smoothly to first in human clinical trials and beyond.
How Psychedelics Are Made
Generally, psychedelics are either naturally derived or synthetic. Psilocybin, mescaline, and DMT are all naturally occurring, while LSD is fully synthetic. Recent research includes the development of second-generation molecules that will hopefully confer the mental health benefits without potentially unwanted side effects.
Types of Mental Health Issues Psychedelics Can Treat
A growing body of research shows promise for psychedelics’ potential to treat depression, anxiety, post-traumatic stress disorder, addiction, and even fear of death. For example, in November 2019, the US FDA designated psilocybin therapy as a “breakthrough therapy” for major depressive disorder. In general, psychedelics, along with dissociative drugs and entactogens, have shown promise for mood, substance use, and anxiety disorders.
Risks of Using Psychedelics as Mental Health Treatment
Psychedelics are generally considered safe but can also contribute to serious side effects, including paranoia, psychosis, and cardiovascular issues. They can also affect the central nervous system, which compromises sound judgment and can lead to accidents. Should your organization move forward with drug development, know that CNS clinical trials will likely be required. Many of the risks associated with psychedelics can be attenuated by having participants take the drugs in a controlled setting with expert supervision provided by trained medical experts.
There are a special set of regulatory challenges for Schedule I drugs. There was a long pause in research on their potential benefits, and psychedelic drugs are often characterized as lacking any acknowledged therapeutic use. There is also the potential for abuse. Due to these and other factors, these drugs are highly controlled and often placed in the most restrictive categories. This can make conducting research and moving to commercialization difficult.
Licensing Requirements for Research
Drug licensing requirements are an important aspect of controlling the use of psychedelics while conducting clinical research. Each country has a different set of licensing conditions. These can strictly limit research for legitimate activities at a qualified testing site. For example, in the US, organizations must have a Schedule I site license for the facilities where the studies will be conducted, such as in Phase 1 clinical trial units. Partnering with a CRO with existing expertise or an existing license can save time and streamline the otherwise challenging process.
Getting a Psychedelic Drug to Commercialization
An additional challenge is getting your psychedelic drug to commercialization. As noted, CNS clinical studies, such as driving tests and human abuse potential, will be required. There may be potential for unexpected after-effects, with additional provisions for longer-term assessment and monitoring.
Altasciences, a mid-sized contract research organization, knows drug development can be a complex process. The Altasciences team will make your organization’s next drug development project smooth and streamlined. As an integrated CRO with pharmaceutical CDMO capabilities, Altasciences offers partners over 25 years of research experience. Many pharmaceutical and biotechnology companies have come to rely on Altasciences’ innovative, integrated approach for preclinical studies, clinical trials, bioanalysis, and formulation and manufacturing. Partnering with Altasciences means gaining their team’s expertise in various therapeutic indications and study types. This includes valuable experience in first-in-human clinical trials and CNS clinical trials. The CRO offers clinical trial partners access to a wide variety of resources, including more than 580 beds, a highly trained and experienced staff, and a recruiting database of over 400,000 potential participants.
Partner with Altasciences for expertise in psychedelic drug development at https://www.altasciences.com/
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