Benzinga | Nov 8, 2021 09:18AM EST

Petros Pharmaceuticals Expands Program For Novel Investigational Non-Invasive Treatment Formulation For Peyronie's Disease

Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a leading provider of therapeutics for men's health, announces today the expansion of its program for investigational H100, a novel patented non-invasive topical treatment under development for Peyronie's disease. H100 is a topical gel formulated to address the inflammatory cascade that leads to pain, scarring and penile irregularities associated with Peyronie's disease. Through its exclusive global license agreement with Hybrid Medical LLC, developer of H100, Petros furthers its commitment to advancing men's health with a product intended to become the first and only clinically-approved non-invasive topical for the treatment of Peyronie's disease.

"Petros's vision is to provide optimized men's health solutions across the spectrum of conditions that are specific to men, whether they be focused on the male anatomy or of increased risk among men," commented Fady Boctor, Petros' President and Chief Commercial Officer. "We believe that if approved, H-100 may be able to provide the first-ever non-invasive treatment to a confounding and often painful condition for which there have been few viable solutions. Importantly, through further studies, it may demonstrate an established safety and tolerability profile which could facilitate a 505(b)(2) submission. This could significantly shorten the clinical development timeline. We look forward to continuing to drive development around this potential treatment."

According to American Urological Association (AUA) Guidelines, among the current treatments for Peyronie's disease are invasive surgeries, injections and implants.[1] As a topical, H-100 has the potential to be approved as the first non-invasive treatment for the condition. Peyronie's (pay-roe-NEEZ) disease is a noncancerous condition resulting from fibrous scar tissue on the penis, causing curved, often painful erections. While not necessarily a cause for larger concern, Peyronie's disease causes an irregularity in the shape of the erection in some men, which may prevent sexual intercourse or might cause difficulty in achieving or maintaining an erection (erectile dysfunction). Penile shortening is another common concern. The condition does not often naturally abate, and in most cases will remain as is or worsen.[2]

According to healthcare advocates, The Men's Health Network, not all irregularly shaped erections or penile bumps are caused by Peyronie's disease and the impact goes beyond the physical symptoms, expanding to include sexual, psychological, and social effects. Because in Peyronie's, the erection shape is abnormal and sometimes hurts, intercourse can become difficult and even impossible for some men. Others can become self-conscious about the appearance and limitations of their erections, causing them to avoid sex. They note that Peyronie's can be embarrassing to talk about -- even with a partner -- which can lead to relationship difficulties. In one study of 92 men with Peyronie's, 48% were reported to have had clinical depression connected with the condition.[3]