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

 Petros Pharmaceuticals, Inc., a leading provider of therapeutics for men’s health, today reports positive over-the-counter (OTC) draft label comprehension study results for its erectile dysfunction (ED) Drug STENDRA^® (avanafil).  This Pivotal Label Comprehension Study was designed to assess comprehension of a draft STENDRA^® Drug Facts Label intended for OTC use.  This study is a key component in the Company’s plans to engage in discussions with the FDA to expand the product’s access through application for a possible OTC pathway.  Early study indicators show positive label comprehension outcomes in the study, which has encouraged the Company to initiate the next step, a Self-Selection Study, as it continues to build the case for the FDA for OTC access to STENDRA.

“The label comprehension study is a key component of our plans to help expand access for STENDRA beyond the prescription model, and to make STENDRA potentially the first  prescription-grade ED medication to become available over-the-counter in the United States.  While the process of gathering data to be shared with the U.S. Food and Drug Administration (FDA) continues, we are enthusiastic about our progress toward providing new hope for the millions of men suffering from this condition,” commented Fady Boctor, Petros’s President and Chief Commercial Officer.  “The switch to OTC is one of many approaches we are currently exploring to expand access to STENDRA. We remain steadfast in our dedication to men with ED by providing new and innovative options to help them safely, securely and discreetly obtain this medication.”

In the study, 453 subjects, including a significant number of low health literacy individuals, reviewed a draft OTC Drug Facts label, and were assessed to determine whether they could correctly understand nine key communication messages in the label.  The comprehension of these nine primary points, combined with an additional 14 secondary messages, is intended to guide an individual’s appropriate selection and use of STENDRA in a potential OTC setting. The Company believes the topline results of this study demonstrate a strong assessment of comprehension of the draft OTC label communication messages, and that these label comprehension results will provide a strong framework for discussions with the FDA regarding the Company’s OTC development program. These label comprehension results also provided the foundation for initiating the necessary self-selection studies, and future actual use behavioral studies, for STENDRA as part of the OTC pathway.

It is estimated that only about 25% of the approximately 30 million men suffering from erectile dysfunction in the U.S. have received oral erectile dysfunction therapy.

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. 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.

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.

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