The ED program is focused on the development of a medicament in the form of a locally applied topical formulation delivering Makefield's novel nitric oxide containing nanoparticle to treat erectile dysfunction in men who are refractory to current treatment options or find the side effects of the current options unacceptable. It has been reported that as many as 50% of men are unresponsive to the PDe5 inhibitors Viagra®, Cialis® and Levitra®. The market potential for this population is over $3 billion.

Men who have undergone prostatectomy for removal of the cancerous gland will often suffer trauma to the cavernous nerve resulting in ED. Although surgical procedures have been improved and nerve sparing is attempted, there is still a significant portion of patients who suffer this outcome resulting in men delaying or refusing a potentially lifesaving intervention out of fear of becoming impotent. Similarly, damage to the cavernous nerve can occur during surgical intervention for the treatment of benign prostatic hyperplasia or enlarged prostate gland. Neuropathy associated with diabetes is yet another cause of nerve damage and ED. The aging baby boomer population is a growing market for safe and efficacious ED treatments.

There is a clear unmet need for new treatments for men who have suffered damage to the cavernous nerve. This population is generally refractory to currently available oral treatments which require stimulation of the cavernous nerve to initiate the cascade of events necessary for a man to achieve an erection.

Stimulation of the cavernous nerve is responsible for beginning the erectile process by activating a biochemical process in the body which causes the production of nitric oxide.  If the nerves are severed, then nitric oxide is not produced and erection is impossible.

Nitric oxide is a naturally occurring chemical found in the human body. NO has a variety of biological functions in the body including activation of an enzymatic system which causes smooth muscle relaxation inside the penis enabling it to fill with blood.  The proposed drug product will supply nitric oxide directly to the corpora or spongy tissue responsible for erection.  Thus, even if the cavernous nerve is severed, nitric oxide is still supplied to the penis and erection can still occur.  This drug product has been successfully tested in rat models in which the cavernous nerve has been severed and has demonstrated efficacy in eliciting an erection in these animals.

The drug product is unique because it is the only known method of storing and delivering gaseous nitric oxide to the target tissue in a clinically acceptable and therapeutically relevant manner.