Interstitial cystitis (IC) is a chronic disease of the bladder characterized by urinary frequency, urgency, nocturia (night-time urination) and pelvic and bladder pain. The most common theories to explain the pathophysiological changes in IC are an altered bladder lining (defective glycosaminoglycan layer) and an increased number of activated bladder mast cells.
Symptoms vary between patients and may vary between episodes in the same patient. The average patient has symptoms for 5 years and visits multiple clinicians before a diagnosis of IC is made. Patients may have extended periods of remission; IC is not a progressive disease. Sufferers of IC can experience any combination of the main symptoms of the condition, and no two people may have the same combination or severity of symptoms. IC patients are more prone to suffer from other medical conditions than would be expected in the general population. The severity of the overall symptoms can considerably affect the quality of life of IC patients and seriously restrict their ability to undertake everyday tasks that are taken for granted by the majority of the population. The impact can be seen by the level of depression experienced by IC patients.
According to the National Kidney and Urologic Diseases Information Clearinghouse, which is a division of the National Institutes of Health, an estimated 1,000,000 patients suffer from IC in the United States, 90% of whom are women. The prevalence of IC in Europe is approximately one-third that of the United States. We believe that IC is currently underdiagnosed and that the market for drugs that treat IC will likely expand with the introduction of effective new treatments.
At present, there is no cure for IC and no treatment that works for every IC patient. Treatments are only designed to relieve the aggravating symptoms of IC. As a result, there are no truly effective treatments for the majority of sufferers. Elmiron® and DMSO are the only medications approved by the Food and Drug Administration (FDA) for the relief of bladder pain or discomfort associated with IC. Elmiron is typically taken as a tablet 3 times per day. Elmiron is believed to repair/replenish the bladder wall, which minimizes the irritation of the bladder lining. For most patients treated with Elmiron, it may take many months before any benefit is experienced. DMSO is injected intravesicularly to reduce bladder inflammation.