Petros Pharmaceuticals Expands Program for Novel Investigational Non-Invasive Treatment Formulation for Peyronie’s Disease
Company developing H-100 with goal to be the first and only FDA-approved topical treatment for Peyronie’s Disease, currently treated predominantly through highly invasive surgery or series of penile Injections
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Nov 08, 2021, 09:15 ET
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NEW YORK , Nov. 8, 2021 /PRNewswire/ — 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.  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:
- take medicines called nitrates, which are used to treat chest pain (angina)
- use street drugs called "poppers," such as amyl nitrate and butyl nitrate
- take medicines called guanylate cyclase stimulators, which include Adempas ® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
- are allergic to avanafil or any of the ingredients in STENDRA
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:
- An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away.
- Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
- Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness.
Before you take STENDRA, tell your healthcare provider if you:
- have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape
- have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions
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:
- medicines called nitrates
- medicines called guanylate cyclase stimulators, such as riociguat
- medicines called HIV protease inhibitors, such as ritonavir (Norvir ® ), indinavir (Crixivan ® ), saquinavir (Fortavase ® or Invirase ® ), or atazanavir (Reyataz ® )
- some types of oral antifungal medicines, such as ketoconazole (Nizoral ® ) and itraconazole (Sporanox ® )
- some types of antibiotics, such as clarithromycin (Biaxin ® ), telithromycin (Ketek ® ), or erythromycin
- medicines called alpha-blockers. These include terazosin (Hytrin ® ), tamsulosin HCl (Flomax ® ), doxazosin (Cardura ® ), prazosin HCl (Minipress ® ), alfuzosin HCl (UroXatral ® ), dutasteride and tamsulosin HCl (Jalyn ® ), or silodosin (Rapaflo ® ). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting
- other medicines that treat high blood pressure
- other medicines or treatments for ED
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.
CBD for Erectile Dysfunction
While comedians sometimes make light of it, and an occasional issue getting or maintaining an erection might be something to chuckle about with your partner after the fact, chronic erectile dysfunction can actually be a devastating condition. One that can interfere with intimate relationships, derail feelings of self-worth, and even cause depression and anxiety. Today we’re going to talk about how utilizing CBD for erectile dysfunction might be able to help men who are struggling with this condition.
CBD for erectile dysfunction at a glance:
- What the claims are: CBD can help relieve the symptoms and many of the issues that can cause (and be caused by) erectile dysfunction.
- What the studies show: We were unable to find any human studies on CBD’s direct effect on erectile dysfunction. Anecdotal evidence suggests that there are many men experiencing higher sex drives and relief from impotence after adopting a CBD regimen.
- What the facts say: While we don’t have conclusive data, due to the established connection between the role of endocannabinoids and mammalian sexual behavior, the need for studies on the potential effects of CBD for erectile dysfunction can’t be overstated.
What exactly is erectile dysfunction?
Erectile dysfunction, also known as impotence, is the inability to get and keep an erection firm enough to engage in sexual intercourse. Occasional bouts of impotence aren’t necessarily a cause for concern, but long-term erectile dysfunction can not only cause all sorts of emotional issues like depression and anxiety, it can also signal underlying health conditions that could need treatment.
Symptoms of erectile dysfunction are pretty straightforward and can include one or more of the following:
- Trouble getting an erection
- Trouble keeping an erection
- Reduced sexual drive
The root cause of erectile dysfunction varies, and is often elusive, as we human beings are a complex species. Sexual arousal involves not just our hormones, nerves, and blood flow. It also involves our minds and emotions. Erectile dysfunction can result from a problem in any of these areas, and can often be cyclical.
For example, if you’re experiencing pain and take a medication with a potential side effect that inhibits sexual response, just the concern or anxiety over that possibility might wind up causing the issue in the first place. As stress and anxiety increase, so might the severity of the condition. In other cases, erectile dysfunction might be caused by an underlying issue or other, physical health concern, such as:
- Heart disease
- Clogged blood vessels
- High cholesterol
- High blood pressure
- Metabolic syndrome
- Parkinson’s disease
- Multiple sclerosis
- Certain prescription medications
- Tobacco use
- Peyronie’s disease — development of scar tissue inside the penis
- Alcoholism or other forms of substance abuse
- Sleep disorders
- Surgeries or injuries
How can CBD be used to help with erectile dysfunction?
CBD for erectile dysfunction can be a potential help as it has been known to increase sex drive as well as create a calm and zen state of mind. In fact, early studies have shown that CBD can alleviate anxiety and even help with depression.
There is also evidence to suggest that CBD can increase blood flow. While we know that helps regulate blood pressure spikes, it could also have something to do with the results many are experiencing when they take CBD for erectile dysfunction.
Medical studies related to CBD for erectile dysfunction
As mentioned above, we were unable to find any studies that dealt with CBD for erectile dysfunciton directly. However, there are some studies on how CBD affects the biological processes related to sexual function.
Our bodies’ endocannabinoid systems play a role in regulating various cognitive and physiological functions. Those functions include our moods and also affect our sexual responses. Because CBD (cannabidiol) interacts with our own cannabinoid receptors, it seems logical that it would also have an affect on our sexual responses and potentially be of help to those suffering from this issue.
There is also evidence that CBD acts as an antioxidant. This could be of help as discussions of harmful toxins causing erectile dysfunction have arisen.
We’re hoping that there will be some clinical trials on the horizon so that we can delve deeper and explore the potential of utilizing CBD for erectile dysfunction.
What are the risks of using CBD for erectile dysfunction?
CBD is considered to be both safe and well tolerated by most who use it. And, according to a recent study by the World Health Organization, it is not associated with abuse potential. That said, some people might not find that CBD helps with their erectile dysfunction.
Due to the potential link between chronic cannabis use and male sexual dysfunction, we should also note that, while CBD is a compound derived from the cannabis plant, it has not been shown to cause sexual issues. In fact, we’re seeing lots of media reports on the exact opposite side of the spectrum.
Should I give CBD for erectile dysfunction a try?
As of this writing, no research has been done on CBD for erectile dysfunction. While research indicates the endocannabinoid system is involved with sexual function, it’s unclear from a scientific standpoint whether CBD could help with erectile dysfunction. That said, anecdotal evidence seems to support that some men are finding that CBD has increased their sex drive as well as their ability to get and maintain an erection.
However, if you are suffering from this issue and find the anecdotes encouraging, CBD’s remarkable safety profile makes it fairly safe to try, providing you’re not taking any medications that will interact with it. Keep in mind that the lack of scientific studies doesn’t mean that it won’t work, just that we don’t know for certain whether or not it does.
As with any change to your healthcare regimen, you should talk to your doctor before adopting a CBD regimen. Especially as there might be a more serious, underlying health issue that needs to be addressed. And, if you’re currently taking any prescription medications, you should check with your pharmacist to ensure that CBD won’t interact with any of them in a negative way.