Compound Danshen Dripping Pill Leah 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: Plus other spices 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: 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

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

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

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

CDDP About Side Effects: Drug Interactions: 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/TCMproductinFDAIIItri als.html?ts=1446563401&signature=b9488109b51f05ce4da2b654b70bf61d&t s=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_Bot Drugs_Aug2009.pdf http://www.webmd.com/vitamins-supplements/ingredientmono-931- danshen.aspx?activeingredientid=931&activeingredientname=danshen