100 million people in the US suffer from a problem for which we have a strong solution and six patents issued.
Wellesley Pharmaceuticals currently in clinical trials for an innovative, patented drug for the treatment of Nocturia. Our proprietary drug, Paxerol™ addresses a substantial unmet clinical need.
Paxerol offers significant advancement in terms of mechanism of action relative to existing indirect treatments of nocturia and should allow us to provide relief to hundreds of millions of people.
Nocturia Incidence US and Worldwide – This unmet medical need is large and growing rapidly. In the US it is estimated that 65% of adults between the ages of 55 and 84 have nocturia at least a few nights per week and millions at younger ages suffer from it as well. That totals over 100 million patients in the US and about 2.2 billion worldwide. Due to demographic trends, that number is expected to continue to grow by about 40 million patients per year, as reported in 2011 by the Official Journal of the British Association of Urological Surgeons.
Nocturia’s Shocking Consequences – With nocturia, awakening 2 to 6 times nightly for a bathroom visit is annoying, but each visit also has the risk of insomnia and raises the odds of chronic diseases, such as stroke and heart disease. The book Nocturia, edited by Jeffrey P. Weiss, et al. and published in 2012, reported on a study that concluded “the annual cost to US society resulting from loss of productivity from nocturia in the <65-year-old population is approximately $61 billion per year.” Moreover, multiple studies show increased morbidity/mortality associated with nocturia, ranging from fatigue and depression to poor work performance and increased rates of hip fractures, which often result in permanent handicaps and/or early deaths.
Perhaps the most shocking data come from the February 2011 Journal of Urology article titled, “Association of Nocturia and Mortality: Results from the Third National Health and Nutrition Examination Survey,” by Varant Kupelian, et al. That survey tracked almost 16,000 people over 12 years and calculated 12-year death rates based on age grouping and nocturia severity. According to the graphs displayed in that article, for men ages 20-49, about 99% of those without nocturia symptoms survived at least 12 years, but for those arising at least 3 times per night to use the bathroom, only about 90% survived. Even more dramatically, for women ages 65-90, about 68% of those without nocturia symptoms survived at least 12 years, but for those arising at least 3 times per night, only about 22% survived 12 years. The results vary depending on age, sex, and nocturia severity, but the overall implications of nocturia seem to be profound in all reported segments. In some cases deaths are caused by middle of the night falls and in other cases they are due to car or industrial accidents of various types due to exhaustion resulting from nocturia. The most frequent causes of death, however, appear to be the implications of chronic sleep loss for inducing strokes, heart disease, and other severe health issues.