What are the botanical drugs?
The term botanical means products that include plant materials, algae, macroscopic fungi, or combinations thereof. It excludes highly purified drug substances, products containing animals or animal parts and or minerals, materials derived from genetically modified botanical species, and fermentation products
Botanical drugs may be available in various forms, including solutions, powders, tablets, capsules, topicals, or injectables.
Single herb, mixture of multiple herbs, and cannabis products are good sources for botanical drug development.
The global market for botanical or plant-derived drugs is expected to grow to $39.6B by 2022 with a compound annual growth rate (CAGR) of 6.1%. The FDA Botanical Drug Development Guidance for Industry defines a pathway for herbal medicines and cannabis-derived products to become prescription drugs in the US.
The American Botanical Drug Association, ABDA, is an industry organization with a mission to:
Increase public awareness of botanical drugs
Increase options in the healthcare system
Facilitate the formation of healthcare policies
Serve as a platform for dialogue and collaboration between government agencies, private entities, and academics, by means of conferences and meetings
Promote collaboration between the pharmaceutical and botanical industries
Establish international standards for botanical drugs and their medical usage
ABDA collaborates with research institutes and companies to evolve safe and effective botanical products into prescription botanical drugs using the FDA's botanical drug development pathway.
The pharmaceutical industry has been thriving for many decades but experienced slowdown in recent years. New drug development methods are needed. The FDA ”Botanical Drug Development Guidance for Industry" opens doors for botanical products like herbal medicines and cannabis-derived products to develop into prescription drugs; if a drug product is a single plant or from a mix of plants, the Guidance waives the requirement of
1) identifying active ingredients,
2) describing the mechanism of action.
As long as botanical products demonstrate safety and efficacy in phases 1, 2, and 3 of clinical trials, they are approved as a prescription medication in the US market. Between 2016 and 2019, 195 botanical drug clinical trials were registered, of which 81 are phase 2. By the end of 2018, over 600 IND applications were in clinical development under the botanical drug category. Two botanical products have been approved as prescription drugs:
Veregen (sinecatechins), a topical drug for the treatment of genital and perinatal warts.
Mytesi® (crofelemer, old name Fulyzaq), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
The ABDA's mission is to facilitate this evolution of botanical drugs into prescription level drugs.
Modern herbal medicines come in pill or capsule form. Their safety and efficacy have been demonstrated by daily use on a large population. Identifying already known effective herbal medicines with promising efficacy is an efficient drug development pathway. ABDA promotes FDA botanical drug guidance and collaborates with entities around the globe to develop herbal medicines into US prescription drugs.
The FDA also issued a draft Cannabis Product Guidance for Industry in order to encourage the development of cannabis-derived products into prescription drugs, using the FDA botanical drug pathway.
ABDA develops research platforms for scientists around the globe to work together to advance technology application in herbal medicine research.
By working with research institutions and entities around the world, ABDA develops and publishes industry standards.