Interstitial cystitis, a urological disorder that is more formally known as interstitial cystitis/bladder pain syndrome (ICBPS), is characterized by chronic pelvic pain, tenderness, and discomfort. Women are four times as likely as men to suffer from ICBPS, with the disease affecting an estimated 3 to 8 million women and 1 to 4 million men in the United States alone.[1] ICBPS can be profoundly debilitating for sufferers: increased urinary frequency and urgency, nocturia, sleep disruption, pain upon bladder filling, and pain during sexual intercourse are all common symptoms. The pathophysiology of the disorder can be ulcerative or non-ulcerative (10% and 90% of cases, respectively), the former involving mucosal hemorrhages in the bladder wall called Hunner’s lesions. The more common non-ulcerative form of ICBPS can be extremely difficult to diagnose and treat adequately, as in these patients, previous urinary tract infections, pelvic floor injuries, neuralgia, and/or somatic pain disorders may be contributing to symptoms. In recognition of ICBPS awareness month this September, we explore some of the key unmet needs and commercial opportunities identified in our recent Chronic Pain | Unmet Need | Detailed, Expanded Analysis: Interstitial Cystitis report.

If the disease is correctly identified and diagnosed, first-line therapies for ICBPS are usually nonpharmacological (dietary changes, physical therapy,  fluid intake, etc.) and are recommended based on a patient’s phenotype (i.e., the observable characteristics of the disease). There are few available oral medications that have evidence of efficacy in relieving urinary pain, frequency, and urgency in ICBPS, and only two pharmacological products are approved specifically for the treatment of the disease (Janssen/bene-Arzneimittel’s Elmiron and Mylan’s RIMSO-50 intravesicular instillation). Our survey of 60 U.S. and 30 European urologists who regularly treat ICBPS patients found that the majority (50-70%) of respondents perceive Elmiron, oral antidepressants, antihistamines, gabapentinoids, and intravesicular treatments as performing moderatelyat best in terms of efficacy, suggesting that there is plenty of room for improvement. Additionally, 88% and 83% of surveyed U.S. and European urologists, respectively, ascribed high unmet need to ICBPS, relatively more than they did to other related pain indications.

There is substantial market opportunity for emerging therapies in ICBPS, especially for therapies that are able to better ameliorate pain symptoms and improve the quality of life of patients than current treatments. However, it is a heterogenous patient population, making it difficult for drug developers to conduct well-designed clinical trials that are able to yield meaningful results. More recent Phase III failures of the emerging therapies LiRIS (Allergan/TARIS) and AQX-1125 (Aquinox Pharmaceuticals) further underscore this point. The type of pain and urinary symptoms experienced by an ICBPS patient are closely linked to patient phenotype, and it is important for developers to carefully consider patient inclusion criteria when designing clinical trials. Developers may choose to investigate emerging therapies’ efficacy for reducing pain intensity in a specific patient subpopulation—for example, evaluating a drug with an anti-inflammatory mechanism of action in ICBPS patients who have cytoscopic evidence of Hunner’s lesions, or evaluating a biologic that targets nociceptors in a broader ICBPS patient population without requiring cytoscopic findings as part of the patient inclusion criteria. By choosing to test treatments in patients with a specific ICBPS phenotype, developers may improve their chances at establishing significant efficacy in late-stage trials.

A therapy that tackles ICBPS symptoms and improves patients’ quality of life is sorely needed, but the pipeline of emerging therapies for ICBPS is sparse. Our survey of U.S. and European urologists found that over 80% of respondents from both regions identified reduction in pain intensity and improvement in quality of life to be the two most important drivers of prescribing choices for the disease. There are a few drugs featuring therapeutic targets novel to ICBPS that may offer improvement on these two efficacy attributes, including tumor necrosis factor alpha (AbbVie’s Humira and UCB’s Cimzia) and nerve growth factor (Astellas’s monoclonal antibody ASP-6294, currently in Phase II development for ICBPS). Astellas’s Myrbetriq, a treatment for overactive bladder, is also being investigated in ICBPS patients in a pilot study. If successful, any of these drugs may be differentiated enough from existing therapies in the market to capture sizable patient share. Hopefully, drug developers will continue to recognize the market opportunity that exists in this underserved patient population and work to discover therapies to better treat ICBPS.

Our Unmet Need report offering on interstitial cystitis is covered as part of DRG’s multiple offerings in the chronic pain space that include the comprehensive Chronic Pain| Disease Landscape & Forecast, the Chronic Pain | Unmet Need | Detailed, Expanded Analysis | Chronic Low Back Pain, and the Chronic Pain | Access & Reimbursement | Detailed, Expanded Analysis (US) reports among many more. Learn more about how DRG can help you quickly identify, analyze, and act on emerging challenges with our disease insights solutions.

[1] www.ic-network.com, accessed September 2018.

 

Related DRG report:

Chronic Pain | Unmet Need | Detailed, Expanded Analysis: Interstitial Cystitis (US/EU)

 

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