Urinary Incontinence
Product Candidate Description
This is a combination of two molecules, both well known but neither previously used for this indication. Patients with a history of incontinence, whether stress, urge, or mixed, administer this formulation at decreasing frequencies as their condition resolves.
Laboratory Status
Work on this product has been restricted to the clinic. No significant lab work has been completed. Because of the nature of the molecules involved, lab efforts would be focused strictly on mechanism-of-action studies.
Clinical Status
Dozens of patients have been successfully treated by several physicians affiliated with BTL. A small, double-blind crossover study was conducted that clearly showed that each of the two components demonstrated some anti-incontinence activity, but that the combination was far superior to the single agents. Some of the treated patients have had no incontinence for years, even after years of daily accidents. Others must maintain reduced frequency of use of the product to maintain total bladder control.
Early experience with only a few patients suggested that this formulation might also be useful for the treatment of fecal incontinence.
No adverse effects have been reported.
Path Forward
The FDA recently approved Beech Tree's Investigative New Drug (IND) application to begin formal clinical trials for its therapy addressing urinary incontinence. In pre-clinical studies, this formulation has demonstrated efficacy with no adverse side effects.
Any laboratory work could be conducted while the clinical trial was underway, so that at the end of the trial a complete product package could be assembled.