The global market for botanical and plant-derived drugs expected to grow to $39.6B by 2022 with a compound annual growth rate (CAGR) of 6.1%. The US FDA Botanical Drug Development Guidance for Industry defines a pathway for herbal medicines to become prescription drugs in the US.
The American Botanical Drug Association is an industry trade organization for world wide herbal and cannabis manufacturers and companies, with a mission to:
Increase public awareness of botanical drugs
Increase options in the healthcare system
Facilitate healthcare policy formation
Serve as a platform for dialogues and collaboration among government agencies, private enteritis, and academics, by means of conferences and meetings
Promote collaboration between the pharmaceutical industry and the botanical and herbal industry
Establish international standards for botanical drugs and its medical usage
ABDA collaborates with research institutes and companies to develop safe and efficacious botanical products to US prescription botanical drugs through FDA botanical drug development pathway.
The pharmaceutical industry has been thriving for many decades but experienced inevitable slowdown in recent years. Chemical drugs are limited in certain disease areas, like virus-induced infection. An additional approach for drug development is needed. The US FDA ”Botanical Drug Development Guidance for Industry” opens doors for botanical products like herbal medicines or cannabis products to be developed as prescription drugs: if a drug product is derived from single plant or from mix of plants, the Guidance waives the requirement of: 1) identifying active ingredients, 2) description of mechanism of action. As long as a botanical product demonstrates safety and efficacy in Phase 1, Phase 2, and Phase 3 trials, they are approved as a prescription drugs on the US market. Two botanical drugs have been approved so far as prescription drugs:
Veregen (sinecatechins), a topical drug for the treatment of genital and perinatal warts.
Fulyzaq (crofelemer), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
Between 2016 to 2019, 195 botanical drug clinical trials were registered, of which 81 are phase 2 or 2/3. Nighty five percent of all phase 2 or 2/3 studies were designed with 100 or fewer patients per arm. By the end of 2018, over 800 IND applications were filed to US FDA under the botanical drug category. The majority of them were allowed to the clinical trial stage. ABDA’s mission is to facilitate the development of botanical drug industry.