Our Goal Pipeline
After several years in development, our current efforts have three critical interdependent goals:
1. Complete Phase 2
Results versus placebo from our Phase 2 clinical trial were 2.5 to 5 times better than the other FDA approved nocturia drugs, both of which carry black box warnings about a dangerous blood disorder. These drugs treat polyuria, which has nothing to do with low nocturnal bladder capacity (NBC), which is the focus of Nocturol. Only 76% of nocturia patients have low NBC, so Nocturol will not help all nocturia sufferers, but the lifestyle instructions distributed with the drug should significantly add to its efficacy even for patients who also suffer from polyuria.
2. Provide Evidence
Our key goal is to provide compelling evidence to the FDA that the once nightly Nocturol pill safely addresses and solves a very serious problem suffered by huge numbers of at-risk citizens. Nocturia’s quality of life implications, the insomnia that is often associated with nocturia, and the resulting exhaustion and depression can have profound health, productivity, and life expectancy effects.
Demonstrating positive sleep enhancing benefits may have a major impact on the speed with which the FDA will evaluate Nocturol’s readiness for approval and availability to the many who need it. This speed should be enhanced when the FDA acknowledges that polyuria and low nocturnal bladder capacity are totally unrelated causes of nocturia; therefore, we are treating a totally unmet medical need.
3. Educate People
In addition to providing the safest and most effective nocturia drug, our goal is to also educate people on the seriousness of nocturia and demonstrate that there is finally a viable safe solution to address the problem, with minimal side effects, if any.
Most people, including many doctors, are completely unaware of the potentially devastating consequences attributable to poor sleep resulting from nocturia. The attached presentation was independently assembled by physicians and describes the implications of nocturia and its often severe consequences:
When we launch Nocturol, we will also provide an in-depth set of lifestyle instructions which can help people maximize the overall improvement in their symptoms. This should prove especially helpful to the 53% of nocturia sufferers who have polyuria (overproduction of urine) as one of their key issues.
