Stress incontinence (SUI) is the most common form of urinary incontinence in women and is characterised by the voiding of urine on coughing, sneezing, laughing, exercising or sitting.
Treatment options are limited to the use of incontinence pads, behavioural therapy, pelvic floor-strengthening exercises, collagen injections or surgical procedures.
In contrast to UUI, the prevalence of SUI is greatest in women aged 45 and under, with over 20 million women in North America and Western Europe estimated to suffer from mild to moderate SUI.
There are no globally approved pharmacological therapies for this condition and many patients rely on the use of pads (adult diapers).
This increasing demand coupled with the lack of approved pharmacological therapies, provide a substantial market opportunity.
PSD503 is a topical gel containing an alpha-agonist which is applied externally around the urethra.
Alpha-agonists have an established benefit in SUI and are thought to reduce urine leakage by restoring the muscular tone of the urethra. However, when taken orally these agents can result in an undesirable increase in blood pressure.
The Plethora approach to treating stress incontinence exploits the clinical benefit of alpha-agonists while avoiding their side effects. PSD503 is delivered locally, producing an optimal clinical response (increased urethral pressure) without the adverse blood pressure effects associated with oral medications.
Plethora has completed a clinical study of PSD503 that showed it to be effective in increasing urethral tone without an adverse affect on blood pressure.
Preliminary analysis from a phase II study, in 12 patients, of the double-blind, crossover placebo controlled study shows that PSD503 produced a 54% overall reduction in leakage (as measured from pad weight). Improvement with PSD503, beyond that of placebo, was reported in 50% of the women with stress incontinence which represents a good responder rate for a urological condition such as incontinence or benign prostatic hyperplasia (BPH). In addition, the cardiovascular side effect profiles of placebo and PSD503 are indistinguishable, with no evidence of blood pressure elevation in any subject. Consistent with this finding, only very low systemic plasma concentrations of phenylephrine are found.
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