Alternative for ED
NO is a potent vasodilator, too, making NO nanoparticles an ideal way to treat erectile dysfunction (ED). Despite widespread use of oral phosphodiesterase type 5 (PDE5) inhibitor drugs for ED, they have several drawbacks such as flushing, headache, and congestion. Moreover, patients with diabetes and other diseases often do not respond to oral PDE5 drugs. A topical treatment could overcome side effects and serve more types of men. “There’s a significant unmet need for better ED drugs,” says Towarnicki.
The nanoparticles can deliver current small molecule ED drugs as well as NO, as reported in January in the Journal of Sexual Medicine.
Topical treatment with nanoparticles encapsulating either NO or tadalafil (Cialis®) produced visible erections in a rat model for ED. There was no evidence of congestion or other side effects. And when oral doses of PDE5 inhibitors are compared to topical delivery in the nanoparticles, the topical formulations perform better, Towarnicki said.
Severed nerves, a consequence of prostatectomy, also cause ED. To simulate this condition, Makefield researchers severed the nerves of healthy young male rats. One week later, a topical dose of NO-nanoparticles spread on the rat penises caused erections.
“These are the exact nanoparticles that are antimicrobial, too,” Towarnicki points out. Different clinical needs can be met by optimizing the release kinetics of the nanoparticles. For instance, an antimicrobial can be designed to release NO for 24 hours at the site of an infection, whereas a treatment for ED would have a higher initial release rate followed by faster depletion.
Makefield Therapeutics plans to advance its therapeutics based on NO nanoparticles through Phase II trials. They will then look for partners for larger clinical trials and marketing.