1. Compound Danshen Dripping Pill
Leah Pinckney

2. What is Compound Danshen Dripping Pill (CDDP)?
Also called cardiotonic pill
Patented Chinese herbal medicine
Created by Tianjin Tasly Pharmaceuticul Co. Ltd.
Successfully completed US Food & Drug Administration (FDA) Phase II ddrug approval

3. CDDP About
Currently sold in China, Vietnam, Pakistan, South Korea, India, & UAE
Taken by 10 million people per year
Used to treat angnia and coronary heart disease
International sales in 2009 = $148 million
IF approved,
Tasly have rights for prescription drug
Have tried for years to get approved
Challenges of botanicals

4. CDDP About Consists fo 4 main components: Plus other spices
Root of Chinese salvia (danshen)
Notoginseng root extract
Synthetic borneol
Ginger
Plus other spices

5. Root of Chinese Salvia // 丹参
Name:
丹 = used to describe cinnabar, deep red color of salvia roots. Unique!
参 = refers to ginseng, most highly respected her in China.
First mentioned in Shennong Bencao Jing (ca 100 AD)
Similar properties to cinnabar and ginseng
Not as versatile, desirable
Used for treating heart disorders

6. Notoginseng // 三七 Name: Wild plants most valuable TCM Properties:
Panax notoginseng
三七 = 3 branches, 7 leaves ea
Wild plants most valuable
TCM Properties:
Warm
Sweet
Slightly bitter
Nontoxic
Used to treat blood disorders

7. Synethic Borneol Name: Origin: Properties/Uses: Elettaria cardomum
Derived from camphor (pungent chemical)
Properties/Uses:
White, colorless lumps
In many essential oils
Natural bug repellant

8. Ginger Name: Origin: Properties/Uses: Zingiber officinale
Indigenous to South China
Properties/Uses:
Promoted as cancer treatment
Effective placebo in treating nausea, osteoarthritis

9. CDDP About Uses: Mechanism: Administered:
Stroke, chest pain, cardiovascular disease
Mechanism:
Thins blood to prevent clotting
Causes vasodilation (widens blood vessels)
Administered:
Orally

10. CDDP About Side Effects: Drug Interactions: Thrombocytopenia
Low blood pressure
Bleeding
Dizziness
Drug Interactions:
Anticouglants
Aspirin
Ibuprofen
Warfarin (Coumadin)

11. FDA Process
Product designated by FDA as investigational new drug (IND) for human clinical trials
CDDP first TCM product to get this in 1997
Phase I: Small group testing
Determine safety, dosage range, side effects
Phase II: Larger group study
Determine safety, efficacy
Phase III: Large groups study
Confirm efficacy, monitor side effects, compare it to common treatments, collect safety info
New Drug Application (NDA) submission

12. FDA Process

13. FDA Process

14. FDA Process

15. FDA Process

16. FDA Process Possible 10 year period after Phase III approval
Long, expensive process
10-15 years from lab  market
$800 million - $1.2 billion for R&D to market
3,000 medicines in development, only 25 approved as of 2009
“CDDP would be first botanical new drug to be approved by FDA, first botanical to achieve cardiovascular indication.” – Freddie Ann Hoffman, MD, former FDA official

17. FDA Process
Veregen Ointment first and last botanical to achieve FDA approval in 2006
German product
Made of phytochemicals from partially purified water extract of green tea leaves
Challenges
Standardization
Safety
Purification and identification of active ingredients
Bioavailability

18. Since the chief raw materials are plants, strict quality control measures for each plant raw material need to be implemented. They include genus/species identification by genotypic, phenotypic and chemical tests; growth conditions; processing methods; shipping and storage; and characterization of adulteration from other plant species. Traditional pharmacopoeial standards established in the country of origin are not sufficient for FDA, but the characterization has to meet FDA requirements as specified in the guidance documents.
US FDA

19. Botanical drug vs food supplement?

20. Sources
als.html?ts= &signature=b b51f05ce4da2b654b70bf61d&t s= &signature=68bb52da878f64fe262a6bbb8a6af0f3
Drugs_Aug2009.pdf
danshen.aspx?activeingredientid=931&activeingredientname=danshen