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Petros Pharmaceuticals Announces Positive Results of Over-the-Counter (OTC) Label Comprehension Study for Erectile Dysfunction Drug STENDRA (avanafil)

Petros Pharmaceuticals Announces Positive Results of Over-the-Counter (OTC) Label Comprehension Study for Erectile Dysfunction Drug STENDRA (avanafil)

Very clear Knowledge of STENDRA OTC Label to be Crucial Element in OTC Growth Software Company is Pursuing

NEW YORK, April 19, 2022 (Globe NEWSWIRE) — Petros Prescription drugs, Inc. (“Petros” or “the Company”) (Nasdaq: PTPI), a main company of therapeutics for men’s health and fitness, right now supplies favourable results from its above-the-counter (OTC) draft label comprehension review for its erectile dysfunction (ED) drug STENDRA (avanafil), which show understanding of the messages therein. These outcomes advise that the draft drug information labeling language as composed might be suitable for submission to the Fda for review for in excess of-the-counter labeling.

The Pivotal Label Comprehension Review compiled 453 label comprehension interviews – which include a significant cohort of lower health and fitness literacy folks – to figure out comprehension of draft drug info labeling for STENDRA. In summary, the proposed about-the-counter (OTC) labeling was nicely comprehended, according to the examine parameters, by individuals individuals who participated. Extra than 95% of participants delivered appropriate or satisfactory responses to questions that evaluated comprehension of 9 primary communication messages. These bundled regardless of whether STENDRA can be applied if an unique can take nitrate medication or does not have erectile dysfunction. Curiously, comprehension amid the low overall health literacy individuals, though modestly reduce than people with improved well being being familiar with, still shown a large level of comprehension.

“The benefits of this label comprehension review support us to carry on to solidify our programs to implement to the Fda to help grow access for STENDRA over and above the prescription design, and, if authorised by the Fda, to make STENDRA potentially the initial prescription-grade ED medicine to turn into available in excess of-the-counter in the United States,” commented Fady Boctor, Petros’s President and Chief Commercial Officer. “The switch to OTC is one particular of many ways we are now checking out to expand access to STENDRA. We stay steadfast in our dedication to gentlemen with ED by giving new and innovative options to help them safely, securely, and discreetly acquire this medication.”

It is approximated that only about 25% of the about 30 million adult men suffering from erectile dysfunction in the U.S. have acquired oral erectile dysfunction remedy.

About STENDRA® (avanafil)

STENDRA® (avanafil), at first launched by Auxilium Pharmaceuticals prior to that firm’s sale to Endo Prescribed drugs, is an oral phosphodiesterase 5 (PDE5) inhibitor for the cure of erectile dysfunction. STENDRA® is not for use in women of all ages or small children. It is not acknowledged if STENDRA® is harmless and effective in ladies or little ones below 18 several years of age. 100-mg and 200-mg tablets can be taken as early as ~15 minutes before sexual action. STENDRA® operates only with sexual stimulation and must not be taken more than the moment a day. STENDRA® can be taken with or with out foods do not drink way too considerably liquor when getting STENDRA® (for case in point, much more than 3 eyeglasses of wine or 3 pictures of whiskey) as it can raise odds of side effects. Of folks enrolled in scientific trials, 1.4%, 2.%, and 2.%, stopped having STENDRA® (50 mg, 100 mg, or 200 mg, respectively) because of to facet results when compared to 1.7% on placebo. STENDRA® was developed and developed expressly for erectile dysfunction. Currently, STENDRA® is coated for ~75% of commercially insured lives, with a co-pay out as low as $. For much more facts take a look at: https://STENDRA.com/.

STENDRA® Significant Danger Facts
STENDRA® can trigger your blood tension to fall instantly to an unsafe stage if it is taken with selected other medications. A sudden drop in blood strain can bring about you to truly feel dizzy, faint, or have a heart assault or stroke.

Do not acquire STENDRA® if you:

  • take medications called nitrates, which are applied to handle chest agony (angina)

  • use street medication referred to as “poppers,” this sort of as amyl nitrate and butyl nitrate

  • choose medicines called guanylate cyclase stimulators, which incorporate Adempas® (riociguat), a medication that treats pulmonary arterial hypertension and serious thromboembolic pulmonary hypertension

  • are allergic to avanafil or any of the components in STENDRA®

Cease sexual activity and get health care aid correct absent if you have indications these kinds of as upper body suffering, dizziness, or nausea through intercourse. Sexual exercise can set an more strain on your coronary heart, specifically if your heart is currently weak from a coronary heart attack or heart sickness. Explore your well being with your health care service provider to guarantee you are healthful enough for sexual intercourse.
STENDRA® can cause severe side outcomes.
Uncommonly described side effects include:

  • An erection that will not go away (priapism). If you have an erection that lasts much more than 4 hrs, get health-related help suitable away.

  • Unexpected vision loss in one or both eyes. Sudden eyesight loss in just one or equally eyes can be a signal of a critical eye difficulty known as non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether or not PDE5 inhibitors instantly induce eyesight loss. Quit taking STENDRA® and connect with your healthcare supplier right absent if you have sudden vision reduction in one or equally eyes.

  • Sudden listening to reduce or listening to loss. Some persons might also have ringing in their ears (tinnitus) or dizziness.

In advance of you consider STENDRA®, notify your healthcare supplier if you:

  • have or have had coronary heart challenges this sort of as a coronary heart attack, irregular heartbeat, angina, or heart failure have experienced heart surgery within just the very last 6 months have experienced a stroke have low blood pressure, or substantial blood stress that is not controlled have a deformed penis form

  • have experienced an erection that lasted for a lot more than 4 several hours have problems with your blood cells, this kind of as sickle mobile anemia, numerous myeloma, or leukemia have retinitis pigmentosa, a scarce genetic (runs in family members) eye ailment have ever experienced extreme eyesight reduction, which includes an eye difficulty known as non-arteritic anterior ischemic optic neuropathy (NAION) have bleeding troubles have or have had belly ulcers have liver issues have kidney challenges or are acquiring kidney dialysis or have any other clinical problems

Notify your healthcare provider about all of the medications you consider, together with prescription and nonprescription medications, natural vitamins, and herbal health supplements. STENDRA® may perhaps impact the way other medicines get the job done, and other medicines may perhaps have an effect on the way STENDRA® performs, which may perhaps result in side effects. Specifically tell your healthcare supplier if you consider any of the pursuing:

  • medicines named nitrates

  • medications called guanylate cyclase stimulators, these types of as riociguat

  • medications called HIV protease inhibitors, this kind of as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®), or atazanavir (Reyataz®)

  • some varieties of oral antifungal medicines, these kinds of as ketoconazole (Nizoral®) and itraconazole (Sporanox®)

  • some varieties of antibiotics, these kinds of as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin

  • medicines called alpha-blockers. These include things like terazosin (Hytrin®), tamsulosin HCl (Flomax®), doxazosin (Cardura®), prazosin HCl (Minipress®), alfuzosin HCl (UroXatral®), dutasteride and tamsulosin HCl (Jalyn®), or silodosin (Rapaflo®). Alpha-blockers are from time to time recommended for prostate challenges or superior blood stress. In some patients, the use of STENDRA® with alpha-blockers can guide to a fall in blood tension or fainting

  • other medicines that address significant blood tension

  • other medicines or treatment plans for ED

Do not drink far too considerably alcoholic beverages (for instance, much more than 3 eyeglasses of wine or 3 pictures of whiskey) when getting STENDRA®, as this can lead to elevated prospects of headache, dizziness, greater coronary heart amount, or reduced blood pressure.
STENDRA® does not protect from sexually transmitted health conditions, such as HIV.
The most popular aspect outcomes of STENDRA® are headache, flushing, stuffy or runny nose, sore throat, and back again agony.
Inform your health care service provider if you have any side impact that bothers you or does not go absent. These are not all of the attainable aspect outcomes of STENDRA®. For far more facts, talk to your health care company or pharmacist. Connect with your healthcare supplier for health-related guidance about facet outcomes.
Make sure you see total Prescribing Information and Individual Information and facts.

About Petros Prescribed drugs

Petros Prescribed drugs is dedicated to the target of becoming a earth-major specialised men’s wellness organization by pinpointing, building, getting, and commercializing ground breaking therapeutics for men’s well being troubles, which include, but not constrained to, erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial conditions, Peyronie’s sickness, hormone health, and compound use disorders.

Cautionary Take note Relating to Ahead-Looking Statements

This press launch features forward-hunting statements within the this means of Segment 27A of the Securities Act of 1933, as amended, and Portion 21E of the Securities Exchange Act of 1934, as amended. These ahead-wanting statements are based mostly on Petros Prescribed drugs, Inc.’s (“Petros,” “we,” “our,” “us” or the “Company”) management’s assumptions, expectations, projections, intentions and beliefs about foreseeable future events. In some cases, predictive, long term-tense or forward-hunting words this sort of as “intend,” “develop,” “goal,” “plan,” “predict,” “may,” “will,” “project,” “estimate,” “anticipate,” “believe,” “expect,” “continue,” “potential,” “opportunity,” “forecast,” “should” and comparable expressions, regardless of whether in the negative or affirmative, are meant to recognize forward-on the lookout statements, but are not the distinctive signifies of pinpointing this sort of statements. Real results and the timing of sure occasions and instances could differ materially from those explained by the ahead-wanting statements as a outcome of pitfalls and uncertainties, which includes, with out limitation, Petros’ capacity to execute on its business enterprise tactic, including its designs to produce and commercialize its solution candidates Petros’ skill to comply with obligations as a general public reporting organization the means of Petros to well timed and successfully implement controls and methods needed by Portion 404 of the Sarbanes-Oxley Act of 2002 the hazard that the economical efficiency of Petros may possibly not be as anticipated by the merger transactions that resulted in the Company’s creation hazards resulting from Petros’ status as an emerging development enterprise, such as that minimized disclosure necessities may well make shares of Petros popular inventory considerably less appealing to buyers threats connected to Petros’ historical past of incurring major losses pitfalls relevant to Petros’ dependence on the commercialization of a one solution, STENDRA®, and on a one distributor thereof dangers related to the termination of Petros’ professional offer arrangement with Vivus, which include the risk that Petros may well not be able to get sufficient portions of STENDRA® in a timely method or on commercially viable phrases risks connected to Petros’ capacity to attain regulatory approvals for, or sector acceptance of, any of its products and solutions or product candidates and the expected or prospective impact of the novel coronavirus (“COVID-19”) pandemic, which includes the emergence of new variants, this sort of as the Delta variant, and the similar responses of governments, individuals, clients, suppliers, workers and the Enterprise, on our small business, operations, workers, economical situation and results of functions. More factors that could induce actual final results to differ materially from the outcomes anticipated in these ahead-searching statements are contained in the Company’s periodic studies and in other filings that the Corporation has filed, or may well file, with the U.S. Securities and Trade Commission (the “SEC”) under the headings “Risk Factors” and “Management’s Dialogue and Assessment of Money Situation and Success of Operations” and in other places. The Enterprise cautions audience that the forward-wanting statements incorporated in this press launch signify our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not supposed to give any assurance as to upcoming benefits. New aspects arise from time to time, and it is not possible for us to forecast all of these factors. Additional, the Organization are unable to evaluate the outcome of every single this kind of aspect on our business or the extent to which any factor, or blend of elements, may possibly induce true final results to be materially distinct from all those contained in any ahead-searching assertion. Appropriately, you must not unduly rely on any forward-hunting statements.

The Company undertakes no obligation to update or revise any ahead-hunting statements contained in this press release, irrespective of whether as a result of new info, foreseeable future activities, a transform in our views or anticipations or in any other case, apart from as needed by federal securities guidelines.

CONTACTS:

Buyers:
Core IR
[email protected]

Media:
Jules Abraham
Main IR
917-885-7378
[email protected]