Compound Danshen Dripping PillLeah Pinckney

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

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

CDDP About

Consists fo 4 main components: Root of Chinese salvia (danshen)

Notoginseng root extract

Synthetic borneol

Ginger

Plus other spices

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

Notoginseng // 三七 Name:

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

Synethic Borneol

Name:

Elettaria cardomum

Origin:

Derived from camphor (pungent chemical)

Properties/Uses:

White, colorless lumps

In many essential oils

Natural bug repellant

Ginger

Name:

Zingiber officinale

Origin:

Indigenous to South China

Properties/Uses:

Promoted as cancer treatment

Effective placebo in treating nausea, osteoarthritis

CDDP About

Uses: Stroke, chest pain,

cardiovascular disease

Mechanism: Thins blood to prevent

clotting

Causes vasodilation (widens blood vessels)

Administered: Orally

CDDP About Side Effects:

Thrombocytopenia

Low blood pressure

Bleeding

Dizziness

Drug Interactions: Anticouglants

Aspirin

Ibuprofen

Warfarin (Coumadin)

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

FDA Process

FDA Process

FDA Process

FDA Process

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

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

“

”

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

Botanical drug vs food supplement?

Sources

http://cms.herbalgram.org/heg/volume7/10October/TCMproductinFDAIIItrials.html?ts=1446563401&signature=b9488109b51f05ce4da2b654b70bf61d&ts=1446611107&signature=68bb52da878f64fe262a6bbb8a6af0f3

http://www.tbiweb.org/tbi/file_dir/TBI2007/TBI2007_2_21.pdf

https://clinicaltrials.gov/ct2/show/NCT01659580

http://www.ncbi.nlm.nih.gov/pubmed/21878380

https://www.amarexcro.com/articles/docs/RAPS_Focus_ChineseMeds_BotDrugs_Aug2009.pdf

http://www.webmd.com/vitamins-supplements/ingredientmono-931-danshen.aspx?activeingredientid=931&activeingredientname=danshen