Petros Pharmaceuticals Completes Pilot Label Comprehension Study to Initiate Process for Stendra® Prescription Erectile Dysfunction Medication to Achieve Designation as an Over-the-Counter Treatment

NEW YORK, July 13, 2021 /PRNewswire/ -- Petros Pharmaceuticals, Inc. PTPI ("Petros," or "the Company"), a leading provider of therapeutics for men's health, today announced it has completed a small label comprehension pilot study, the first step in a process to obtain over-the-counter (OTC) status from the U.S. Food and Drug Administration (FDA) for its erectile dysfunction (ED) medication, Stendra®. 

Stendra (avanafil), is an FDA-approved, prescription oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of ED

"There is clearly an unmet need for increased availability of safe and effective ED medications," said Fady Boctor, Petros President and Chief Commercial Officer. "Pursuing the pathway toward over-the-counter status is an attractive approach.  While not every prescription product is appropriate for non-prescription access, Petros has initiated steps, in line with the FDA's guidelines, to advance expanding product access beyond the prescription designation. Our first Label Comprehension Study demonstrated very promising results and produced highly productive data regarding how the label influences behaviors, and we have already initiated a Phase 2 study, which may ultimately be considered the pivotal study, to continue the FDA-guided pathway toward an application for OTC designation.

"Currently, there are no prescription-grade oral ED therapies that have been approved for OTC status in the U.S.," Mr. Boctor added. "If approved for OTC status by the FDA, Stendra would be among the first oral ED therapies to gain such a designation. Our mission at Petros Pharmaceuticals remains resolute: we aim to enhance access, affordability, and accommodation to meet the consumer at their preferred point of care. We are optimistic following these initial early results and will continue to work closely with and follow the guidance of the FDA to ensure effective label communication and take each additional mandated step to achieve the OTC designation."

The Label Comprehension Study evaluated the understanding of 31 subjects who read a draft over-the-counter drug facts label for an erectile dysfunction drug. In the study, a promising  90% or more of the subjects provided either a correct or acceptable response to 19 of the 22 label messages within the study. The Company has initiated a Phase 2 follow-on to this initial study, which is a more significant and larger Label Comprehension Study that will include low health literacy individuals as part of a multi-step process to develop the necessary behavioral study evidence for the FDA to evaluate Stendra for possible OTC designation. This Phase 2 study may potentially serve as a pivotal study, based on outcomes and other factors.

It is estimated that over 30 million men in the U.S. 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, and for many the hurdles to gain access to reliable solutions from a physician can be equally challenging.

Initiating the OTC Pathway

The FDA considers applications for prescription products to be taken over-the-counter based on a number of factors which demonstrate that there is an acceptable safety margin and where the potential for abuse or misuse is low. In addition, applicants must show that consumers can self-diagnose their condition and both appropriately select and use the product consistent with label instructions without requiring the guidance of a healthcare professional. Based on the results from the Phase 1 Label Comprehension Study and those from the larger and more comprehensive Label Comprehension Study to follow, the Company intends to meet with the FDA OTC Division in the coming months to validate Stendra's pathway towards OTC status.

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, 1.4%, 2.0%, and 2.0%,  stopped taking Stendra (50 mg, 100 mg, or 200 mg, respectively) 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. For more information visit: https://stendra.com/.

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.

SOURCE Petros Pharmaceuticals, Inc.