Following Encouraging FDA Feedback Petros Pharmaceuticals Initiates Self-Selection (Phase 2-Equivalent) Study for STENDRA

Rhea-AI Summary

Petros Pharmaceuticals announces initiation of self-selection study for potential OTC version of STENDRA, an erectile dysfunction medication

Positive

• Petros Pharmaceuticals is collaborating with the FDA to expand access to STENDRA as the first potential OTC prescription-grade therapeutic option for erectile dysfunction (ED)
• Petros has sufficient funding to achieve development goals and near-term clinical milestones for STENDRA
• The FDA provided encouraging guidance about the STENDRA Drug Facts Label (DFL), paving the way for Petros to enter the next phase of research in the OTC development program
• Positive self-selection data and FDA clearance could lead to an actual use trial, potentially making STENDRA the first ED drug approved OTC
• STENDRA is the only FDA-approved drug in its class that currently enjoys patent protection, which could significantly expand Petros' market opportunity

Negative

• None.

Important step towards STENDRA potentially becoming the first erectile dysfunction medication to successfully achieve OTC Status

NEW YORK, NY / ACCESSWIRE / October 19, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs, announces initiation of a self-selection study using the Drug Facts Label (DFL) tested during its previously announced label comprehension study (LCS).

Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We continue to collaborate with the FDA as we pursue an emerging pathway to expand access to STENDRA as the first potential OTC prescription-grade therapeutic option for erectile dysfunction (ED). We believe we have sufficient funding to achieve our development goals as well as significant near-term clinical milestones for STENDRA."

Petros now launches this self-selection study in a simulated OTC setting that allows potential users to determine if they are appropriate candidates to use STENDRA based on their understanding of the label and personal medical history. This study is akin to a Phase 2 study in clinical development sequencing and is the next step in the Company's FDA-guided pathway towards a possible OTC version of STENDRA, the Company's prescription erectile dysfunction drug.

At a recent meeting with the Company, the FDA provided encouraging guidance about the STENDRA DFL, paving the way for Petros to enter the next phase of research in the OTC development program, a Self-Selection Study (SSS). The FDA was forthcoming about its appreciation of the potential public health benefit of addressing men's sexual health with nonprescription medication to treat ED.

Mr. Boctor continued, "This next phase of research, the SSS, will also explore a technology component that may optimize the self-selection results. We look forward to providing additional information about this study as it proceeds as well as about our ongoing dialogue with the FDA. As previously disclosed, if we achieve positive self-selection data and upon FDA clearance, we would expect to move expeditiously into an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing.

"Because STENDRA has the potential of becoming the first ED drug approved OTC and is the only FDA-approved drug in its class that currently enjoys patent protection, we are hopeful that it may significantly expanding Petros' market opportunity, with positive impacts to our growth and profitability. The FDA is in the process of finalizing regulations that create new options for developing safe and effective nonprescription products, and we are carefully navigating those options as we design our studies. As a result, we believe our developmental methodology may ultimately become a model for future programs seeking to switch prescription products to OTC marketing status," concluded Mr. Boctor.

About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know-how as a proven platform for other prospective prescription therapeutics.

About the OTC Pathway
The process of switching a prescription medication to over-the-counter (OTC) first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must show that consumers can make an appropriate decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA ordinarily requires a consumer-tested OTCDFL. This testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.

The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool or the additional conditions may use other approaches that support the switch process.

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.

STENDRA is a prescription medicine used to treat erectile dysfunction (ED). 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.

For more information about Stendra, call 844-458-4887. If you would like to report an adverse event or product compliant, please contact us at 844-458-4887.

You are encouraged to report adverse events related to prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Patient Information.

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," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and 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, 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; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; risks related to Petros' dependence on the commercialization of a single product, STENDRA®; 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.

Contacts
Investors:
CORE IR
ir@petrospharma.com

Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com

SOURCE: Petros Pharmaceuticals, Inc.

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FAQ

What is Petros Pharmaceuticals announcing?

Petros Pharmaceuticals is announcing the initiation of a self-selection study for a potential over-the-counter (OTC) version of STENDRA, an erectile dysfunction medication.

What is the goal of the self-selection study?

The goal of the self-selection study is to determine if potential users are appropriate candidates to use STENDRA based on their understanding of the label and personal medical history.

What is the significance of STENDRA potentially becoming the first OTC erectile dysfunction medication?

If STENDRA becomes the first OTC erectile dysfunction medication, it could significantly expand Petros Pharmaceuticals' market opportunity and potentially have positive impacts on their growth and profitability.

What has the FDA provided guidance on?

The FDA has provided encouraging guidance about the STENDRA Drug Facts Label (DFL), which is a positive development in the OTC development program.

What could happen if the self-selection data is positive and the FDA clears it?

If the self-selection data is positive and the FDA clears it, Petros Pharmaceuticals could move forward with an actual use trial, potentially making STENDRA the first OTC erectile dysfunction drug.

What is the current status of STENDRA in terms of patent protection?

STENDRA is currently the only FDA-approved drug in its class that enjoys patent protection, which could be advantageous for Petros Pharmaceuticals in terms of market opportunity.