The FDA's "Botanical Drug Development Guidance for Industry" represents a significant opportunity for botanical products, including herbal medicines and cannabis-derived products, to potentially evolve into prescription drugs. Under this guidance, if a drug product is derived from a single plant or a mixture of plants, certain traditional requirements are waived, including the need to:
Identify Active Ingredients: Botanical drugs may not be required to identify specific active ingredients within the plant or plant mixture.
Describe the Mechanism of Action: The mechanism of action, which explains how a drug exerts its therapeutic effects, may not need to be fully described in cases of botanical products.
Instead, the emphasis is placed on demonstrating safety and efficacy through rigorous clinical trials. If botanical products can establish their safety and effectiveness in phases 1, 2, and 3 of clinical trials, they have the potential to gain approval as prescription medications in the U.S. market. This streamlined approach recognizes the unique complexities of botanical substances and aims to provide a pathway for their regulatory approval while ensuring patient safety and therapeutic benefit.
Botanical Drug Facts:
Between 2016 and 2019, there were a total of 195 clinical trials registered for botanical drugs. Among these trials, 81 were in Phase 2, indicating an advanced stage of development.
As of the end of 2018, there were more than 600 Investigational New Drug (IND) applications in clinical development within the botanical drug category. This substantial number reflects the growing interest and research efforts in exploring botanical substances for potential therapeutic use and underscores the importance of botanical drug development in the pharmaceutical industry.
Two early approved botanical drugs are:
Veregen (Sinecatechins): Veregen is a topical medication used for the treatment of genital and perianal warts (condylomata acuminata). It contains sinecatechins, which are derived from green tea leaves, specifically Camellia sinensis. Veregen is applied directly to the warts and is indicated for external use.
Mytesi® (Crofelemer, formerly known as Fulyzaq): Mytesi is an oral medication that contains crofelemer as its active ingredient. It is used for the control and symptomatic relief of non-infectious diarrhea in adult patients living with HIV/AIDS who are on antiretroviral therapy (ART). Crofelemer is derived from the latex of the Croton lechleri tree, commonly known as Dragon's Blood.
These approvals marked significant milestones in the acceptance of botanical products as prescription medications and demonstrated their potential therapeutic value in addressing specific medical conditions.
The ABDA (American Botanical Drug Association) plays a crucial role in promoting the FDA's botanical drug guidance and actively collaborates with various organizations worldwide to further the research and development of herbal medicines. Their efforts focus on advancing the transformation of well-established, safe, and effective herbal medicines into botanical drugs through the FDA Investigational New Drug (IND) process. This approach is could be a new and efficient drug development pathway.
By following the FDA's guidance and utilizing the IND process, herbal medicines can undergo rigorous evaluation to meet the necessary regulatory standards for safety and efficacy. This pathway not only ensures that herbal medicines are held to the same high standards as conventional pharmaceuticals but also provides a structured framework for their development and eventual approval as prescription medications. This approach can benefits our society by introducing safe and effective treatment for unmet medical conditions.