Napo Pharmaceuticals Announces Publication of Paper on Crofelemer for Indication of Irritable Bowel Syndrome

Update: Fulyzaq (crofelemer) Now FDA Approved - December 31, 2012

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec 23, 2008 - Napo Pharmaceuticals, Inc., (“Napo”) announces that a paper entitled “Evaluation of Crofelemer in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome Patients” (D-IBS) has been published in the Digestion – International Journal of Gastroenterology, 2008;78:180-186. The paper was authored by Allen W. Mangel, MD, PhD of RTI Health Solutions and Pravin Chaturvedi, PhD, President and CSO of Napo.

The paper discusses the results of a study of crofelemer dosed at 125, 250 and 500mg, twice daily for 12 weeks. Male and female patients were enrolled in the study. Female D-IBS patients showed improvement in the proportion of pain- and discomfort-free days during treatment with 500 mg crofelemer: month 1 (crofelemer vs. placebo: 17.7 vs. 10.2%, p = 0.098); month 2 (23.5 vs. 13.3%, p = 0.076); month 3 (26.1 vs. 10.6%, p = 0.0076). No benefit was seen in male D-IBS patients. Crofelemer was well tolerated.

Conclusion: Crofelemer increased the number of pain- and discomfort-free days in female D-IBS patients. Reduction in pain free days has historically been recognized as a key endpoint for IBS indications. Further studies with crofelemer are warranted to evaluate it as a potential visceral analgesic agent for the treatment of not only D-IBS patients, but also those patients with constipation-predominant and alternating IBS.

On December 10, 2008 Napo announced the licensing of crofelemer to Salix Pharmaceuticals, Inc. for all indications in North America, Europe (excluding certain smaller countries), and Japan, and certain indications, which includes IBS, worldwide. Crofelemer is currently in a final Phase 3 for the indication of chronic diarrhea in people living with HIV/AIDS, under SPA agreement with the FDA and as part of a fast-track review process.

An abstract of the paper is below:

Background: Crofelemer improves bowel function in several conditions characterized by states of prominent secretory diarrhea. Aim: This double-blind, randomized, placebo-controlled trial evaluated the effects of 3 dose levels of crofelemer in patients with diarrhea-predominant irritable bowel syndrome (D-IBS). Methods: Male and female patients were randomly assigned to receive crofelemer 125, 250 or 500 mg or placebo twice daily for 12 weeks. The primary efficacy measure was a responder for improvement in stool consistency. In addition, abdominal pain- and discomfort-free days, pain and discomfort scores as well as other bowel function parameters (such as stool frequency and consistency, urgency, bloating) were evaluated. Results: Two hundred and forty-two D-IBS patients were randomized. Crofelemer did not produce significant improvement in stool consistency (primary endpoint), stool frequency, urgency or adequate relief. However, female D-IBS patients showed improvement in the proportion of pain- and discomfort-free days during treatment with 500 mg crofelemer: month 1 (crofelemer vs. placebo: 17.7 vs. 10.2%, p = 0.098); month 2 (23.5 vs. 13.3%, p = 0.076); month 3 (26.1 vs. 10.6%, p = 0.0076). No benefit was seen in male D-IBS patients. Crofelemer was well tolerated. Conclusions: Crofelemer did not produce benefit on bowel function; an increase in the number of pain- and discomfort-free days in female D-IBS patients was seen. Further studies with crofelemer are warranted to evaluate it as a potential visceral analgesic.

Copyright © 2008 S. Karger AG, Basel

About Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. Napo was founded in November 2001, and is based in California, USA with a subsidiary in Mumbai, India.

Napo's late-stage proprietary gastro-intestinal compound, crofelemer, is in various stages of clinical development for four distinct product indications, including a late-stage Phase 3 program:

-- CRO-HIV for AIDS diarrhea, Phase 3

-- CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2

-- CRO-ID for acute infectious diarrhea (including cholera), Phase 2

-- CRO-PED for pediatric diarrhea, Phase 1

The FDA has granted fast-track status to CRO-IBS and CRO-HIV.

Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Napo also plans to develop an early clinical stage product, NP-500, for the treatment of insulin resistant diseases of Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions, and Napo has entered two screening relationship associated with this collection.

Napo has collaborations with Salix Pharmaceuticals, Inc., Glenmark Pharmaceuticals Limited of India and AsiaPharm Group Ltd. of China.

For more information please visit www.napopharma.com.

 

 

Contact: Napo Pharmaceuticals, Inc.
Lisa Conte, 415-516-2732
lconte@napopharma.com
Charles Thompson, 650-616-1903
cthompson@napopharma.com

 

Posted: December 2008

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