In order for a drug to be sold as medicine in America, a sponsor company must meet the Federal Drug Administration’s requirements for proof of being both safe and effective. Even though Ayahuasca has been used by humans for hundreds of years, it is still important to answer these questions within the framework of modern science.
OUR FDA DEVELOPMENT PLAN
PHASE IA TRIAL
We are currently developing a Phase I clinical trial to study the safety of using Ayahuasca tea in healthy volunteers in a clinic setting. With only a few participants, this study will test the effect of different doses of the medicine, to learn more about what happens to a person’s body during an Ayahuasca session. This study will also help us understand how to optimize our approach to supporting patients through the Ayahuasca session.
In our clinical trials, we aim to give Ayahuasca in a group therapy setting. We choose group therapy, over individual therapy for multiple reasons - to provide more community support to patients in their healing journey, and to lower the cost of the therapy, to make it accessible to more people. We feel confident that giving Ayahuasca in a group setting will enhance the patient experience.
BOTANICAL DRUG DEVELOPMENT
A botanical product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or a combination thereof.
There are three regulatory pathways for botanical products in the US:
Botanical Drug 505
Intended for use in diagnosis, cure, mitigation, treatment or prevention of disease in humans.
Dietary Supplement- DSHEA 1994
Not intended to make a disease claim to diagnose, cure, mitigate, treat or prevent disease in humans.
Holds a confirmed monograph in the OTC drug monograph database, recognized by USP-NF
Botanical drug products (BDPs) are standardized plant extracts. These extracts are standardized to the plant’s bioactive constituents, which are the plant’s secondary metabolites. These metabolites are formed in response to the growing conditions or environment in which the plant is exposed to. Therefore, the growing conditions of the plant can greatly affect the final concentration of bioactive constituents, by percentage of mass, of harvested plant material (Botanical Raw Material-BRM).
The bioactive constituents have varying solubility requirements based on the chemical structure of the molecule. The menstruum (medium used for extraction) of standardized plant extracts is chosen based on the solubility of the bioactive constituents needed for standardization and the projected stability requirements of the final BDP. A designated variance is often incorporated into the analytical identity of standardized BDP, accommodating the inherent variability of constituent concentration of BRM. This variance is usually determined by the manufacturer and approved by the FDA. It is based on the analytical lot to lot variability of their plant source (farm), an analysis done early in the development of the BDP.
We know that plant medicine presents chemistry and standardization challenges. However, these are not insurmountable. FDA provides expert botanical medicine guidance to the few whole plant/fungal medicine researchers. In December 2016 FDA released its updated ‘Botanical Drug Development: Guidance for Industry’.