Petros Pharmaceuticals, Inc., 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. 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.
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.
About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a world-leading specialized men’s health company by identifying, developing, acquiring, and commercializing innovative therapeutics that address the men’s health landscape. The Company’s current commercialized portfolio includes patented Stendra® (avanafil), an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction as well as a line of market leading ED therapeutic devices. Topical H-100™ gel is the Company’s prospective treatment under development for Peyronie’s disease. Please see below for Important Safety Information for Stendra.
Petros seeks to establish new foundations for the field of men’s health by collaborating with researchers, scientists, medical thought leaders and payers on therapies that restore men’s body function to vitality. petrospharma.com
About STENDRA (avanafil)
Stendra® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company’s sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra® was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra®, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra® with a well-funded commercial organization and refocused strategy.
STENDRA Important Risk Information
STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
Do not take STENDRA if you:
Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex.
STENDRA can cause serious side effects.
Uncommonly reported side effects include:
Before you take STENDRA, tell your healthcare provider if you:
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects. Especially tell your healthcare provider if you take any of the following:
Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.