LONDON, UK (GlobalData), 23 August 2012 - Both the current filed status and Phase III pipeline for irritable bowel syndrome (IBS) are sparse. The recent marketed products specific to IBS are almost non-existent, but many therapies that are used to treat IBS are off-label drugs or alternative therapies. The drugs which have been FDA approved in the past and are still in use interestingly have indications for women only, such as Amitiza (lubiprostone [8mg]) and Lotronex (alosetron HCL). Of the few previously approved IBS drugs, one has been suspended (Zelnorm (tegaserod) in 2007 from the US market for serious adverse effects) and others have black-box warning labels and are rarely prescribed (such as Lotronex). The reason why the pipeline is only trickling may hinge on two questions: does gender play a role in developing an effective mechanism of action (MOA)? Or is the pathophysiology of IBS so tricky that it hinders development of effective drugs? As there are no systematic reviews to confirm whether IBS is more common in women, gender analyses have not been able to draw conclusions except that women are more likely to report their symptoms and to experience IBS with constipation and nausea compared to men. Since IBS is a syndrome and not a disease, the exact etiology and pathophysiology is difficult to study, which may lead to the treatment of symptoms and not the exact mechanism of the syndrome.
IBS is broken up into three subtypes: IBS-C (with constipation), IBS-D (with diarrhea), and IBS-M (mixed). The prevalence among countries varies, but the estimated prevalence in the US in 2011 was 12%. Prevalence is known to be slightly higher in women; however, the prevalence across the subtypes varies based on gender. Although IBS is not considered a life-threatening illness and does not lead to gastrointestinal cancers, it becomes a physical and mental anguish for those diagnosed with it. IBS may be chronic and relapsing in nature; therefore, it may then become a socioeconomic burden as patients have higher work absenteeism and may have a poor quality of life due to effects of the condition.
There are a few drugs in the research drug pipeline which have been filed globally; Phase III pipeline products number less than 10, however. Common off-label therapies prescribed for IBS include antispasmodics and antipsychotic drugs, such as Bentyl (dicyclomine) and Norpramin (desipramine), respectively. These drugs are used to treat the cramping and pain which is generally associated with symptoms of IBS. For those diagnosed with IBS-D, therapies generally include an antidiarrheal such as Imodium and bile acid binding agents such as Questran; for women who have severe IBS-D, Lotronex may be prescribed. Patients suffering from IBS-C are prescribed therapies such as Amitiza (for women) and osmotic laxatives such as Milk of Magnesia or stool softeners such as Miralax. Patients are prescribed therapies to help with their symptoms as there are no therapies to treat the condition itself; therefore, these factors become an unmet need.
The current global market for treating IBS is estimated at $689m and expected to increase to over $1.4 billion by 2018. Come September 7, 2012, the IBS treatment paradigm may have an actual approved therapy from Ironwood Pharmaceuticals, Inc., a company located in Cambridge, MA. The oral peptide drug, known as linaclotide, is a guanylate cyclase type-C agonist (GCCA) and is indicated for the treatment of IBS-C and chronic constipation. Clinical trial data has shown the GCCA drug reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. GlobalData believes that linaclotide will be a fast-selling drug, as it will target a larger population of the IBS patients’ subtypes (including men) than the previous and current therapies.
There are several other drugs spanning the subtypes of IBS in Phase III development. Tioga Pharmaceuticals of San Diego, CA is developing a previous Merck product known as asimadoline. Originally developed for peripheral pain, it is an oral kappa opioid receptor agonist. This candidate is ideal for IBS suffers, because these receptors are found in the digestive tract and may play a role in stomach pain and bowel motility. Clinical trial data has been generated showing promising safety and efficacy profiles in patients with IBS-D.
Furiex Pharmaceuticals, Inc., located in Morrisville, NC, is producing a drug for IBS-D known as MuDelta. MuDelta is considered a first-in-class mixed mu (µ) opioid receptor agonist and delta opioid receptor antagonist with low oral bioavailability. The dual modulation treats diarrhea and pain associated with gastrointestinal (GI) tract malfunctions, but without the sedative effect or reverse bowel motility, which can lead to constipation. Also, this therapy was given a fast-track designation by the FDA.
Lastly, Rottapharm/Madaus is based out of Italy and is developing CR 2017, dexloxiglumide. This cholecystokinin (CCK)-1 receptor antagonist controls secretory functions in the digestive system specific to visceral motility and sensory pathways. Preliminary Phase III European clinical trials data showed efficacy in IBS-C patients, but also in other GI-related indications such as dyspepsia and gastroesophageal reflux disease. Currently, the data is under review with the FDA and European Medicines Agency to discuss further steps needed for approval.
Even though there is very little in the ‘upper’ pipeline for IBS, what is likely to come to market will provide great benefit to those with the condition. GlobalData believes these drugs will reach a broader population of IBS suffers as they are currently targeting men and women with all subtypes of IBS.
Pushing the IBS Pipeline for Promising Therapies
This expert Insight was written by GlobalData immunology and neurology analyst, Dina Rufo. For more information or to enquire about an interview please contact our press office via the details below.
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