FDA Grants Meeting to Petros Pharmaceuticals to Discuss Label Expansion of Erectile Dysfunction Drug STENDRA®
Petros Pharmaceuticals (Nasdaq: PTPI) received approval for a meeting with the FDA scheduled for September 2021 to discuss potential labeling changes for its erectile dysfunction medication, STENDRA® (avanafil). Proposed modifications include adjustments to the nitrate contraindication, allowing for twice-daily dosing under certain conditions, inclusion of clinical study results for patients post-radical prostatectomy, and updates on endothelial function effects. The aim is to enhance STENDRA's profile and accessibility, especially as over 30 million men in the U.S. suffer from erectile dysfunction, but many remain untreated.
- Scheduled FDA meeting in September 2021 to discuss STENDRA labeling changes is a significant step for product development.
- Proposed twice-daily dosing could increase patient accessibility and enhance usage.
- Potential for label expansion to include results from Phase III clinical studies for radical prostatectomy patients could boost market presence.
- Dependence on a single product, STENDRA, poses significant risks for business sustainability.
- The requirement for regulatory approval for proposed label changes may lead to delays in product relaunch success.
NEW YORK, July 27, 2021 /PRNewswire/ -- Petros Pharmaceuticals, Inc. (Nasdaq: PTPI) ("Petros," or "the Company"), a leading provider of therapeutics for men's health, today announces it has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss expansions and modifications to the labeling of its erectile dysfunction (ED) medication, STENDRA® (avanafil). The meeting is currently scheduled for September, 2021.
Stendra (avanafil), is an FDA-approved, prescription oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of ED.
"We are grateful for the opportunity to review our label with the United States Food and Drug Administration and to propose some potential changes that we believe the breadth and depth of clinical experience with STENDRA may warrant. The granting of this meeting with the agency follows closely our initiation of activities that we hope will result in a separate request to consider bringing STENDRA over the counter. We believe both paths will help to enhance the profile of STENDRA and we look forward to receiving the Agency's guidance on both," said Fady Boctor, Petros' President and Chief Commercial Officer.
The Company will discuss the following potential area of the STENDRA prescribing information during the meeting with the FDA, as well as the potential steps necessary to achieve them:
Nitrate Contraindication – Petros is proposing that the time interval between administration of STENDRA and nitrates be revised to provide greater specificity across the product strengths and more precisely reflect the available clinical evidence. For patients who may have taken STENDRA 50 or 100 mg, given that the effective half-life has been shown to be shorter than two hours and that STENDRA's pharmacokinetics is linear up to an oral dose of 800 mg (AUC), the Company will suggest that more precise ranges may be of value and clinical importance to healthcare professionals. Nitrate use is clearly contraindicated with the PDE5 inhibitor class.
- Twice Daily Dosing - Petros is proposing to modify the dosage so that STENDRA can be taken twice within 24 hours, provided that the maximum dose in a day is less than 200 mg. As with all PDE5's the current dosing is a maximum of once a day irrespective of the strength consumed.
- Radical Prostatectomy – The Company is requesting that the FDA allow the inclusion of results from a Phase III clinical study among ED sufferers following radical prostatectomy into STENDRA's label. Previously announced data has shown that treatment with STENDRA at doses of 100mg and 200mg has demonstrated statistically significant improvement in all three primary efficacy variables relative to placebo in this patient population.
- Endothelial Function –Petros is proposing to modify the U.S. prescribing information to indicate the impact that STENDRA has on endothelial function based on results from a recent, previously announced published clinical study.
"While the PDE5 inhibitor class of erectile dysfunction drugs has a respected history, we believe that the data collected on STENDRA may further differentiate it from other drugs in the class. In particular, while the interaction of PDE5s with nitrates has long been acknowledged, we are looking forward to sharing data that may better elaborate on timeframe for nitrate use after taking STENDRA," continued Mr. Boctor. "In addition, there are several other opportunities that we believe may provide greater patient benefit by expanding the appropriate use of STENDRA in certain contexts, including in men who underwent radical prostatectomy and increased dosing flexibility. We look forward to sharing our data with the FDA and discussing the additional necessary steps toward modification of the STENDRA label, and thereby the patient populations that may benefit from treating their erectile dysfunction with STENDRA."
It is estimated that, just in the US, over 30 million men suffer from erectile dysfunction (ED) and despite more than 20 years since prescription solutions first became available, roughly 3 out of every 4 sufferers remain untreated. The burden of suffering for men and couples can be devastating.
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. 100-mg and 200-mg tablets can be taken as early as ~15 minutes before sexual activity. Stendra works only 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,
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 may include 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' history of incurring significant losses; risks related to Petros' substantial dependence on the commercialization of a single product, Stendra, and on a single distributor thereof; risks related to Petros' commercial supply agreement with Vivus, including the risk that Petros may not be able to obtain sufficient quantities of Stendra in a timely manner or on commercially viable terms; risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates; and the expected or potential impact of the novel coronavirus pandemic, and the related responses of governments, consumers, customers, suppliers, employees and the Company, on our business, operations, employees, financial condition and results of operations. 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.
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SOURCE Petros Pharmaceuticals, Inc.
FAQ
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