IRRITABLE BOWEL SYNDROME (IBS)

IBS-D is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 11 million Americans and 15 million in the European Union.  Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact.  IBS-D can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms.  

ACCOY

ACCOY is developing patents pending drug plus the ACCOY System combination IBS medications with improved efficacy and safety profiles.  Each ACCOY drug ensures the drug is efficacious for the patient, is dispensed as prescribed, and is not dispensed, even if prescribed, if it may result in a dose-mediated adverse event.  The point of care data assists in drug titration and patient management by objectively documenting the relationship between time of dispensing and drug efficacy.

________________________________________________
[1] Inadomi J.M., Fennerty M.B., Bjorkman D. "The Economic Impact of Irritable Bowel Syndrome." Alimentary Pharmacology & Therapeutics. 2003 18(7): 671-682. Accessed 4.21.15 at http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2036.2003.t01-1-01736.x/epdf 
[2] Dr. Michael Camilleri, AGAF, President Elect, AGA.
[3] According to Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research (the FDA office that will review cilansetron)
[4] MMC International used the over 20 year old population - conservatively estimated to be 580 million in 2015.
[5] The Menarini Group, http://www.menarini.com/Home/Innovation-Research/Our-research/Ibodutant/The-disease, May 25, 2015.
[6] Rome IV is the name for the fourth permutation of the Diagnostic Criteria for Functional Gastrointestinal Disorders (FRID)
[7]  Irritable Bowel Syndrome Clinical Presentation, Criteria for Diagnosis, MedScape, by Jenifer K Lehrer, MD; Chief Editor: BS Anand, MD, et al., May 12, 2015.

Significant Unmet Need

"IBS represents a serious strain on health-care systems.  It is the seventh most common diagnosis among all physicians and is the most common diagnosis made by gastroenterologists.[1]  Despite that, public awareness of IBS falls behind other chronic illness, such as diabetes or heart disease or even digestive diseases like Crohn's disease or ulcerative colitis or celiac disease."[2]  Estimates indicate 28% of gastroenterologists and 12% of general practitioners (the two specialties that predominately treat IBS) appointment requests originate from IBS symptoms.   

IBS is characterized by significant unmet needs.  For some people, IBS can be quite disabling, and no one medication works for all patients suffering from IBS[3].  IBS, also called spastic or nervous colon, is quite common.  Thompson Reuters  estimates that between 718 million and 789 million people suffer from IBS worldwide[4].  Most estimates indicate a global IBS prevalence of around 12%.   

Societal Costs 

While IBS is not life-threatening, IBS is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with a significant impairment in the patient's quality of life.  According to the International Foundation for Functional Gastrointestinal Disorders (IFFGD), “approximately 20% to 40% of all visits to gastroenterologists are due to IBS symptoms”.  “Average community health care costs are over 50% higher for patients with IBS than for those without IBS.  In the EU, the total costs of IBS treatment amount to about 30 billion euro/year.  In addition, a study estimated that IBS patients miss three-fold more working days than those without intestinal symptoms.”[5]  

What Is IBS  

IBS is a chronic disease with symptoms that tend to come and go.  The overall prognosis for patients with IBS depends on the severity and frequency of symptoms, and the patient's ability to control these symptoms, whether by diet, lifestyle changes, and/or medications.  IBS (a functional gut disease which cannot be explained with macroscopic abnormalities in gut structure or gross alterations of the normal biochemical mechanisms at the gastrointestinal level) is a chronic, relapsing gastrointestinal disease, characterized by abdominal pain, increased gas, bloating, cramps, and changes in bowel habits.  There is no known diagnostic test or cure for IBS.  However, IBS does not lead to serious diseases such as cancer and doesn't shorten a person's life span.  

Rome IV [6]  

According to Rome III criteria, Irritable Bowel Syndrome (IBS) consists of diarrhea (IBS-D), constipation (IBS-C), a mixed of these two symptoms (IBS-M), or un-subtyped (IBS-U) pattern.  However, the usefulness of the IBS subtypes in the clinical setting is debatable.  Notably, within one year, 75% of patients change subtypes, and 29% switch between IBS-C and IBS-D.[7]  The focus is on the percent of the population that is treated for the particular symptoms at any point in time.  

IBS-D  

IBS-D accounts for about one third of the IBS cases with a global prevalence of around five percent (5%).  MMC International segmented IBS-D into mild (31% of mild IBS-D patients), moderate (24%) and severe (25%) IBS-D responders and non-responders to current therapy.