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, notes a new report from GlobalData.
The drugs which have been US Food and Drug Administration 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).
Gender role
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