FDA Approves Crofelemer as First-Ever Oral Botanical Drug

          FDA Approves Crofelemer as First-Ever Oral Botanical Drug

PR Newswire

AUSTIN, Texas, Jan. 2, 2013

Amazon tree-derived medicine cleared for usage in HIV patients with diarrhea

AUSTIN, Texas, Jan. 2, 2013 /PRNewswire-USNewswire/ --The following is being
released by the American Botanical Council:

(Logo: http://photos.prnewswire.com/prnh/20100430/DC95601LOGO)

On New Year's Eve of 2012, the US Food and Drug Administration (FDA) announced
its approval of crofelemer (Fulyzaq™, Salix Pharmaceuticals, Ltd., Raleigh,
North Carolina) — marking the second time a botanical, and the first time an
orally administered botanical, has received drug approval from the
Administration.(1) The first botanical drug to be approved in the United
States was a topical green tea extract, Veregen®, in 2006.(2) Both botanical
drugs meet all US pharmaceutical requirements and can be dispensed only by

Crofelemer is the first drug to be approved in the United States to treat
HIV-associated diarrhea.(1) It is derived from the latex of the South American
sangre de drago tree (dragon's blood, Croton lechleri).(2) A red,
blood-resembling latex leaks from the tree when its bark is cut, and it is
this substance that contains the novel polymolecular structure crofelemer,
originally developed and standardized by Shaman Pharmaceuticals.

According to FDA's press release regarding the approval, "The safety and
efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive
patients on stable antiretroviral therapy [ART] with a history of diarrhea
lasting one month or longer... Results showed that 17.6 percent of patients
taking Fulyzaq experienced clinical response compared with 8 percent taking
placebo. In some patients, a persistent anti-diarrheal effect was seen for 20

The herbal medicine and pharmaceutical communities have been expressing
satisfaction with FDA's decision, ushered out the door on the last day of the
year — an action typical of FDA efforts to complete pending drug reviews
before the end of each calendar year.(3) Salix, which owns the license for
crofelemer's development and submitted the product's New Drug Application
(NDA) for review, called the approval a "significant step forward in
addressing the unmet medical need of people with HIV/AIDS on ART who
experience non-infectious diarrhea."(4) According to a Salix press release,
the company expects Fulyzaq to be available to patients in early 2013. A
Bloomberg analysis estimates crofelemer will bring the company sales of $18
million in 2013 and $26 million in 2014.(5) ^ Napo Pharmaceuticals (San
Francisco, California), the company that owns the intellectual property rights
of the drug, will issue comments in the coming days (S. King, email, January
2, 2013). Glenmark Pharmaceuticals, Ltd., the India-based manufacturer and
supplier of crofelemer for the US market, experienced an increase in market
shares of 3.4 percent following the announcement.(6)

The drug's approval marks an important event in the decades-long history of
crofelemer. The original Investigational New Drug (IND) application was
submitted by the now-defunct Shaman Pharmaceuticals (formerly in San
Francisco, CA) in the early 1990s. In 2002, Shaman CEO Lisa Conte reorganized
into Napo Pharmaceuticals, retaining Shaman's original intellectual
property.(2) In 2008, Salix obtained a license from Napo in order to continue
to work toward crofelemer drug approval.

Salix filed the NDA for crofelemer in December 2011, which initiated the FDA
review period. Due to the serious nature of the medical condition crofelemer
treats, FDA assigned the NDA "priority review" status, which indicates that
the Administration will aim to approve or reject the application in
approximately six months.(2) Although FDA accepted the NDA for filing in
February 2012, it delayed its decision twice, including the most recent delay
in September 2012, which added to Napo's concerns regarding the length of time
it was taking Salix to move the product forward. In May 2011, Napo filed a
legal complaint for breach of contract against Salix before the New York State
Supreme Court, claiming that Salix was "unnecessarily stalling the advancement
of this compound." Salix has maintained that it has proceeded with the NDA
expeditiously. Although the lawsuit is still pending at this time, a ruling is
yet to be determined.

Updated and more extensive information on the crofelemer approval will be
reported in the January issue of the American Botanical Council's monthly
e-newsletter HerbalEGram, to be published online next week. Additional
background on crofelemer is available in the following articles previously
published by the American Botanical Council:

FDA Delays Decision on Crofelemer for Second Time. HerbalEGram. Volume 9,
Number 11, November 2012.
Dragon's Blood Herb Profile. HerbalGram 92. Winter 2011. Pages 1-4.
Blood of the Dragon: The Sustainable Harvest and Replanting of the Croton
lechleri Tree. HerbalGram 84.Winter 2009. Pages 56-65.


1. FDA approves first anti-diarrheal drug for HIV/AIDS patients [press
release]. Silver Spring, MD: US Food and Drug Administration; December 31,
2012. Available at:
Accessed January 2, 2013.

2. Mader L. FDA delays decision on crofelemer for second time. HerbalEGram:
Volume 9, Number 11, November 2012. Available at:

3. Carroll J, McBride R. Last-minute drive at FDA added 6 new drug approvals.
FierceBiotech. January 2, 2012. Available at:
Accessed January 2, 2013.

4.FDA approves Fulyzaq™ (crofelemer) 125 mg delayed-release tablets for the
symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral
therapy (ART) [press release]. Raleigh, NC: Salix Pharmaceuticals, Inc.;
January 2, 2013. Available at:
Accessed January 2, 2013.

5. Edney A, Bostick R. Salix wins FDA approval of dragon's blood drug for
diarrhea.Bloomberg.December 31, 2012. Available at:
Accessed January 2, 2013.

6. Shah A. Glenmark shares rise on Salix drug approval. Livemint. January 1,
2013. Available at:
Accessed January 2, 2013.

About the American Botanical Council
Founded in 1988, the American Botanical Council is a leading international
nonprofit organization addressing research and educational issues regarding
herbs, teas, medicinal plants, essential oils, and other beneficial
plant-derived materials. ABC's members include academic researchers and
educators; libraries; health professionals and medical institutions;
government agencies; members of the herb, dietary supplement, cosmetic, and
pharmaceutical industries; journalists; consumers; and others in over 81
countries. The organization occupies a historic 2.5-acre site in Austin,
Texas, where it publishes the peer-reviewed quarterly journal HerbalGram, the
monthly e-publication HerbalEGram, the weekly e-newsletter "Herbal News &
Events," HerbClips (summaries of scientific and clinical publications),
reference books, and other educational materials. ABC also hosts HerbMedPro, a
powerful herbal database, covering scientific and clinical publications on
more than 240 herbs. ABC also co-produces the "Herbal Insights" segment for
Healing Quest, a television series on PBS.

ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information:
Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900.
Website: www.herbalgram.org.Contact: Public Relations.

Contact: Public Relations – publicrelations@herbalgram.org (512) 926-4900

SOURCE American Botanical Council

Website: http://www.herbalgram.org
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