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Market Opportunity for Treatment of Overactive Bladder (OAB)
According to an article published by the Mayo Foundation for Medical Education and Research, overactive bladder is a fairly
common malady as approximately 17 million individuals in the United States and more than 100 million worldwide are afflicted.
Importantly, the condition worsens as people age with one in four women and one in ten men aged 65 or older presenting with the
disease.
Although not life-threatening, for the individual overactive bladder is inconvenient, potentially embarrassing, and may disrupt sleep; while significantly impacting quality of life. Frequently these individuals are afraid to leave their home, or are unable to participate in a lengthy meeting, dinner, or social event. Unfortunately, many of these people hesitate to seek treatment because they think their symptoms are a normal part of aging. This mindset is incorrect as overactive bladder is not normal, is treatable, and treatment can significantly ease symptoms and improve quality of life.
Patient compliance studies report that more than half of patients taking an oral OAB drug stop taking it within six months of initiation of therapy. Such studies also report that only 10 to 20 percent of people remain on an oral OAB medicine six to 12 months after initiating treatment. About a third to one-half of those who discontinue their drug therapy do so due to side effects, they simply can not tolerate the drug or do not find the minimal benefit they receive to outweigh the negative effects of the drug.
Importantly, given these efficacy and side effect limitations, the overactive bladder market has still experienced significant and
constant double digit annual growth. According to sales data provided by the four largest U.S. pharmaceutical companies in their
annual reports, Urigen estimates that in the five year period 2000 through 2004 sales of OAB drugs in the United States grew from
$636 million to more than $1.3 billion, and year over year percentage increases for this five year period were 40%, 25%, 18%, and
13%, respectively.
Product Development
Urigen is developing an IND to initiate an exploratory study to evaluate the safety and efficacy of a intraurethral suppository to treat the symptoms of acute urinary urgency associated with overactive bladder.
URG301
Market Opportunity for Treatment of Acute Urethral Discomfort (AUD)
Medical procedures involving instrument insertion into the male or female urethra can be a painful experience for many patients. Nevertheless, cystoscopy and catheterization are common medical procedures performed in a variety of medical specialties on an outpatient basis to examine the urinary tract and the bladder for polyps, strictures, abnormal growths and other problems.
Product Development
Urigen is considering developing a urethral suppository that contains lidocaine in a generally recognized as safe, or GRAS,
approved carrier base. Upon insertion, the suppository would melt promptly and distribute the drug to the urethral tissue achieving a
rapid anesthetic effect.
URG301
Market Opportunity for Treatment of Urethritis
A significant percentage of patients with CPP have a substantial urethral component to their disease. The severity of urethral pain and discomfort may compromise the administration of intravesical therapies. To overcome this problem, Urigen intends to evaluate potential development of a urethral suppository to resolve this pain and discomfort.
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