Recently Published Research on Stendra®(avanafil) for Endothelial Function in Men with Erectile Dysfunction to Initiate Petros Pharmaceuticals' Plans for Expanded Labeling
NEW YORK, March 18, 2021 /PRNewswire/ -- Petros Pharmaceuticals, Inc. (Petros or the Company) (NASDAQ: PTPI), a leading provider of therapeutics for men's health, today announced the publication of preliminary research on the investigational use of Stendra® (avanafil) for endothelial function in men with erectile dysfunction (ED). Stendra is an FDA-approved prescription treatment for erectile dysfunction currently available in the US. Petros plans on using this research to initiate discussions with the FDA on expanding the label for Stendra for the indication to potentially include improvement in endothelial function. Endothelial dysfunction is the impaired functioning of the lining of the blood vessels, which is associated with a reduction in the levels of nitric oxide in the blood vessel walls1. Like diabetes, hypertension, and dyslipidemia, endothelial dysfunction is also a common co-morbidity of erectile dysfunction.
"Following on a previous label expansion we will engage in dialogue with FDA to further expand the labelled indications for Stendra," said Fady Boctor, Petros Pharmaceuticals' President and Chief Commercial Officer. Stendra was FDA approved in 2013. In 2014, a supplemental new drug application for Stendra was FDA-approved, resulting in Stendra becoming the only prescription ED medication indicated to be dosed as early as approximately 15 minutes (100mg and 200mg doses only) before sexual activity. The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain. Please see below for additional Important Safety Information.
The study, which was published online on January 2021 in the peer-reviewed journal Andrologia, reports that Egyptian males who received daily avanafil (in this case, branded Atconafil from Egypt) had statistically significant improvement in nitric oxide (NO), cyclic guanosine monophosphate (cGMP), endothelin-1 (ET-1), and erectile function (based on International Index of Erectile Function questionnaire – or IIEF-5), levels from baseline compared to placebo, regardless of co-morbidity and severity of erectile dysfunction.2 The efficacy and safety of these findings have not been evaluated by health authorities. The study authors noted that, "limitations of this study were the small sample size and the short period for follow up. More studies with larger numbers of patients are required to verify these findings."
The prospective, randomized, double-blind placebo-controlled study was conducted on 140 adult heterosexual males who experienced symptoms of erectile dysfunction (as defined by the National Institutes of Health Consensus Development Panel on Impotence) and impaired endothelial function. Study subjects were randomized to receive daily avanafil (50mg) on an empty stomach or placebo. Study subjects also had comorbidities, including diabetes, hypertension and dyslipidemia, which are associated with a reduction in endothelial function. Subjects were evaluated at baseline and after the four-week treatment period using IIEF-5 scores, which rates ED by 5 levels of severity, and serum levels of NO, cGMP,ET-1, and erectile function. The primary outcome of this study was the percentage of change of NO, cGMP and ET1 serum levels from baseline to 4 weeks post-treatment with avanafil. The secondary outcome was comparing avanafil with placebo group regarding post-treatment NO, cGMP and ET1 serum levels and percentage of change from baseline.
"This study can provide important perspective on how ED is currently treated and the potential for treatments in the future," added Mr. Boctor.
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. Currently, Stendra® is covered for ~75% of commercially insured lives, with a co-pay as low as $0.
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.
Please see full Prescribing Information and Patient Information.
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 for men's health issues including, but not limited to erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial ailments, Peyronie's disease, hormone health and substance use disorders.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should" and similar expressions, whether in the negative or affirmative, are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, including, without limitation, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to comply with obligations as a public reporting company; the ability of Petros to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act of 2002; the risk that the financial performance of Petros may not be as anticipated by the merger transactions that resulted in the Company's creation; risks resulting from Petros' status as an emerging growth company, including that reduced disclosure requirements may make shares of Petros common stock less attractive to investors; risks related to Petros' ability to continue as a going concern; risks related to Petros' dependence on the commercialization of a single product, Stendra®, and on a single distributor thereof; risks related to Petros' commercial supply agreement with Vivus; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.
The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.
1 https://www.verywellhealth.com/endothelial-dysfunction-1746344
2 https://onlinelibrary.wiley.com/doi/10.1111/and.13833
SOURCE Petros Pharmaceuticals, Inc.
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