New FDA-Approved Labeling for Petros Pharmaceuticals’ STENDRA (avanafil) Now Includes Efficacy Data Regarding Use in Men Who Have Undergone Radical Prostatectomy

Rhea-AI Summary

Petros Pharmaceuticals has expanded the FDA labeling of its erectile dysfunction drug STENDRA (avanafil) to include new clinical trial data. The study involved 286 men post-radical prostatectomy, demonstrating significant improvements in erectile function with doses of 100 mg and 200 mg. The company aims to enhance access to STENDRA, including potentially offering it over-the-counter. The label expansion reflects ongoing cooperation with the FDA to include previously unrepresented patient populations.

Positive

• Expanded FDA label for STENDRA includes new efficacy data for men post-radical prostatectomy.
• Clinical trial showed statistically significant improvement in erectile function for both 100 mg and 200 mg doses.

Negative

• None.

Expanded STENDRA Labeling Now Includes Data on a Significant Population of Men Not Previously Included Following Submission of Additional Clinical Trial Data

NEW YORK, NY / ACCESSWIRE / October 25, 2022 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a leading provider of therapeutics for men's health, today announces the expansion of the FDA labeling for its oral erectile dysfunction (ED) drug, STENDRA^® (avanafil), marketed by its subsidiary, Metuchen Pharmaceuticals. The expanded label now includes positive clinical trial data on STENDRA^® (avanafil) use by men with ED who have undergone radical prostatectomy.

The clinical trial included in the new FDA-approved labeling evaluated 286 patients with ED following radical prostatectomy in a randomized, double-blind, parallel, placebo-controlled fixed dose trial of 3 months in duration. For study inclusion, patients had to experience ED following bilateral, nerve-sparing radical prostatectomy. Study subjects received STENDRA^® (avanafil) 100 mg or 200 mg once daily. A statistically significant improvement in all 3 primary efficacy variables relative to placebo was found for both studied doses.

"Our ongoing goal remains to expand access of STENDRA to as many men who need it as possible," commented Fady Boctor, Petros's President and Chief Commercial Officer. "Whether it is through a label expansion that now includes a significant population of men who were not covered under the previous labeling, or ultimately applying to ensure that STENDRA can be obtained OTC, we believe every opportunity to increase the availability of STENDRA is an opportunity to improve the lives of more men who suffer from ED. We are grateful to the FDA for their ongoing collaboration in this label expansion and will continue to work closely with the Agency moving forward."

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.

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 nitrite and butyl nitrite
• 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 had a sudden decrease or loss of hearing;
• have bleeding problems;
• have or have had stomach ulcers;
• have liver problems;
• have kidney problems or are having kidney dialysis.

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, causing 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 or vericiguat
• medicines called HIV protease inhibitors,
• some types of oral antifungal medicines, such as ketoconazole and itraconazole
• some types of antibiotics, such as clarithromycin, telithromycin, or erythromycin
• medicines called alpha-blockers. These include terazosin, tamsulosin HCl, doxazosin, prazosin HCl, alfuzosin HCl, dutasteride and tamsulosin HCl, or silodosin. 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 increased heart rate, lowered blood pressure, dizziness or getting a headache.

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 complaint, 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.

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.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans", " expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, Petros Pharmaceuticals' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; risks related to Petros Pharmaceuticals' history of incurring significant losses; risks related to Petros Pharmaceuticals' dependence on the commercialization of a single product, STENDRA, and on a single distributor thereof; risks related to Petros Pharmaceuticals' ability to obtain sufficient quantities of STENDRA in a timely manner or on commercially viable terms; risks related to Petros Pharmaceuticals' 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, including the emergence of new variants, and the related responses of governments, consumers, customers, suppliers, employees and Petros Pharmaceuticals, on Petros Pharmaceuticals' business, operations, employees, financial condition and results of operations. A discussion of these and other factors, including risks and uncertainties with respect to Petros Pharmaceuticals, and other factors described in Petros Pharmaceuticals' most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the Securities and Exchange Commission, which can be reviewed at www.sec.gov. Petros Pharmaceuticals disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact

IR@PetrosPharma.com

Media:

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

SOURCE: Petros Pharmaceuticals, Inc.

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FAQ

What does the new FDA labeling for STENDRA include?

The new FDA labeling for STENDRA includes clinical trial data showing its efficacy for men with erectile dysfunction following radical prostatectomy.

How many patients were involved in the STENDRA clinical trial?

The clinical trial included 286 patients who experienced erectile dysfunction after undergoing radical prostatectomy.

What were the results of the STENDRA clinical trial?

The clinical trial found statistically significant improvements in erectile function with both 100 mg and 200 mg doses of STENDRA.

What is the significance of the STENDRA label expansion?

The label expansion allows Petros Pharmaceuticals to reach a larger patient population previously not covered, enhancing accessibility to STENDRA.

When was the FDA label expansion for STENDRA announced?

The FDA label expansion for STENDRA was announced on October 25, 2022.