NEW YORK, NY / ACCESSWIRE / September 11, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over the counter (OTC) pathway provides the below Letter to Shareholders:
To our valued shareholders,
As we approach the fourth quarter of 2023, Petros has been quietly undergoing a change in approach to our business. As we have previously announced, our evolving focus has shifted from prioritizing the commercialization of prescription STENDRA, which continues to be a source of revenue for us, to developing and executing on a new pathway toward non-prescription or potentially over-the-counter access for our current lead product. As part of our strategy, we are utilizing new proposed FDA rules to safely bring mature Rx products to the market without the requirement of an authorized prescription. Importantly, we believe that the pathway we are developing may also serve as a template for bringing other mature Rx products that may be similarly appropriate to utilize.
Today we launch our newest investor presentation, which outlines the pathway, as well as a multitude of milestones along the way, some of which have already been achieved. These milestones range from the creation and testing of a consumer-facing label to help ensure that only those men appropriate for STENDRA use are accessing it, to the development of technology to help ensure the safety of those men. The development of this technology has already begun and provides several opportunities to utilize a variety of current advancements, including the potential use of machine learning/artificial intelligence. We are currently exploring several potential partnerships that we believe will help to create the optimal technology and to help position Petros into the future as a leader in the Rx to OTC switch.
Further, our management and certain members of our Board of Directors have experience in the execution of marketing former Rx products into the OTC arena, and we are gathering a team of additional advisors to help ensure that our work is in accordance with current and potential FDA regulations, and optimized to a market that must change its mindset from that of prescription medication to OTC.
We hope the new presentation provides ample explanation of our new approach, as well as the pathway we have laid out in terms of potential milestones in the near future. We look forward to sharing our progress along the way and thank you for your continued support of Petros Pharmaceuticals.
President and Chief Commercial Officer
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 or nonprescription treatment options. Currently, Petros is pursing increased access for its flagship prescription ED therapy, STENDRA, for potential OTC or nonprescription designation. If ultimately approved and designated by the FDA for OTC or nonprescription access, STENDRA may be the first in its class to achieve the designation, 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) involves the design of a clear to laymen, shelf-friendly medication label, demonstrated comprehension of key safety parameters, and proven, appropriate consumer self-selection. The FDA ordinarily requires a consumer tested OTC Drug Facts label (DFL), Label Comprehension Studies (LCS), Self Selection Studies (SSS), and at least one Actual Use Trial (AUT) demonstrating safe and appropriate non-practitioner-guided, yet consumer-led use. Recently, a communication by FDA introduced Additional Conditions for Non-prescription Use (ACNU) criteria that may expand OTC access to several prescription medications and enable innovative tools to help 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.
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 regain and 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®; risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates; and the long term impact of the novel coronavirus ("COVID-19"), 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.
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