Chronic constipation is a very common gastrointestinal disorder. Up to 26 million Americans suffer from the disorder, and of this population about 5 million have a severe condition necessitating relief. The prevalence of the disorder is similar in other developed countries. Patients with chronic constipation often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with chronic constipation can experience serious discomfort which adversely affects their ability to work and their quality of life.
Irritable Bowel Syndrome
Up to one sixth of adults experience inflammatory bowel syndrome (IBS), a condition marked by disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder (IBS-M). The spit in prevalence between the forms is about 1/3rd each. In addition, most patients suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated 10 M people in the US and an additional 10 M people in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of adult visits to primary care physicians in the US.
Inflammatory bowel disease
Inflammatory bowel disease (IBD) consists of two related conditions; Crohn’s disease and ulcerative colitis (UC). Crohn’s disease can affect any part of the intestine, but usually occurs in the small bowel. UC occurs only in the lining of the colon. IBD is less prevalent than chronic constipation or IBS, but the medical need in IBD is very high. About 430,000 people suffer from Crohn’s disease in the United States and about 400,000 in the EU. There are approximately 700,000 people with UC in the US and 500,000 in the EU.
Available products and development pipeline
There are currently few therapies available for chronic constipation or IBS-C. The main product in this market, Zelnorm from Novartis Pharmaceuticals (NYSE: NVS), was withdrawn in the US due to cardiotoxicity in April 2007. In 2006, Zelnorm sold about $561 million with about a 30% growth rate at the time of withdrawal. There are at present only about 5 products in clinical development for chronic constipation and IBS-C. There are more products available for IBD. The latter condition is frequently treated with immuno-suppressive drugs, mesalamine derivatives and steroids. There is still a considerable need for better drugs for IBD.
- Datamonitor report DMHC2260. Inflammatory Bowel Disease. 2006.
- Datamonitor report DMHC2292. Irritable Bowel Syndrome. 2007.
- Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004 Apr; 99(4):750-9.
- Bracco A, Kahler K. Burden of chronic constipation must include estimates of work productivity and activity impairment in addition to traditional healthcare utilization. Am J Gastroenterol. 2004;99:S233.
- Schiller LR, Dennis E, Toth G. Primary care physicians consider constipation as a severe and bothersome medical condition that negatively impacts patients’ lives. Am J Gastroenterol. 2004;99:S234.
- Irvine EJ, Ferazzi S, Pare P, et al. Health-related quality of life in functional GI disorders: focus on constipation and resource utilization. Am J Gastroenterol. 2002;97:1986-1993.