Erectile Dysfunction
As many as one in four adult males experience ED with a consequent impact on both patient and partner. The advent of phosphodiesterase inhibitors (PDEi’s), the first of which being Viagra (sildenafil), revolutionised treatment of this condition. Since approval in 1997, Viagra has been shown to be safe and effective. However, it has been well documented that PDEi’s are less effective in clinical settings where there is metabolic dysfunction (obesity and diabetes) and post certain surgical procedures, particularly radical prostatectomy. In the case of diabetics with ED, less than half will have an adequate response to PDEis and the response in patients following radical prostatectomy is even lower – thereby creating a significant, poorly met medical need.
The great medical need for effective therapy for men refractory to Viagra (PDEi) therapy is growing with the increasing incidence of both metabolic disease robotic surgical prostatic procedures..
Viagra and other PDEis were considered to be highly effective and, as such, the ultimate in patient management. As a result there has been limited research into identifying therapies for treating patients who do not respond to Viagra. Erectile function is essentially a hydraulic event dependent on blood flow into and out of the penile vasculature. In normal male physiology, the sympathetic nervous system also plays a major role and acts as a counter balance to penile blood flow by causing the penis to become flaccid. PDEi’s predominantly act only on one aspect of this process. Only with a detailed understanding of physiology, biochemistry and pharmacology can novel therapies be designed. With this strategy in mind, coupled with extensive clinical observation, RestoriT, has been developed.