NEW YORK, July 19, 2022 (GLOBE NEWSWIRE) — Petros Pharmaceuticals, Inc. (Nasdaq: PTPI), a leading provider of therapeutics for men’s health, today announces that it has signed a compensated collaboration agreement with physician Dr. Drew Pinsky (“Dr. Drew”) to raise awareness, foster dialogue, educate, and alleviate the stigma of erectile dysfunction (ED) and sexual dysfunction within the men’s health and wellness landscape. Through this collaboration, Dr. Drew will expand awareness of Petros Pharmaceuticals’ mission in the men’s health category and provide greater education around its flagship pharmaceutical therapy STENDRA (avanafil) especially as Petros continues to work with the FDA to pursue Over The Counter (OTC) designation.
“Dr. Drew continues to be a key figure in educating the public regarding sensitive health topics using his unique perspective and public health platform. We believe this social media program will help to further raise Petros’s profile in the men’s health category, where we have dedicated our resources toward creating a diversified offering of clinically supported options to health problems unique to men, including erectile dysfunction and Peyronie’s disease,” said Fady Boctor, Petros Pharmaceuticals’ President and Chief Commercial Officer. “We believe his emphasis on the importance of patient self-care, and his ability to breathe new life into hidden, ignored, or avoided issues, such as sexual and erectile dysfunction, run parallel with our ongoing efforts to increase patient access to STENDRA (avanafil), by pursuing OTC designation as well as to increase its awareness among a population looking for alternative options.”
As a public health advocate for topics long considered sensitive, Dr. Drew’s influential opinions and perspectives should help educate consumers about non-invasive treatment options available for common conditions, which may include Petros’s ED therapy STENDRA (avanafil) (see indications and important safety information below), as well as its potential treatment under development for Peyronie’s disease. It is estimated that more than 30 million men in the U.S. suffer from ED and despite more than 20 years since prescription solutions first became available for this condition, roughly three out of every four sufferers remain untreated 1,2. Peyronie’s disease, which impacts as many as one in eleven men, is a connective tissue disorder of the penis that can cause bent erections, erectile pain and scar tissue that creates palpable penile lumps and/or penile curvature3.
“I am pleased to begin to discuss Petros Pharmaceuticals’ leadership on important men’s health topics, which have consistently been difficult for men to discuss openly or comfortably. Destigmatizing sensitive health issues – through open and frank discussion – is paramount to self-care and enjoying good overall health – for you and for your partner. I look forward to showing my audience that they have an advocate to widen access to treatment options that treat these difficult conditions,” added Dr. Drew.
Dr. Drew has been a ubiquitous fixture both on television and radio for the entirety of his multi-faceted career. With more than two decades of syndicated celebrity voice as an acclaimed physician and public health advocate, his long television resume includes Loveline, Celebrity Rehab with Dr. Drew, and many others. He represents the spirit of genuine transparency and dialogue — especially around taboo topics that often burden individuals experiencing them in silence or in isolation — including sex, substance abuse, and addiction. Dr. Drew has a considerable social media following, with more than 2.6 million followers on Twitter, more than 130,000 on Facebook and more than 45,000 subscribers to his YouTube channel.
About Dr. Drew
As a practicing internal medicine physician, addiction specialist, and prolific broadcaster, Dr. Drew’s career has imbued him with the rare ability to examine any issue through the lenses of practical experience, scientific evidence, and pragmatism. He is a two-time New York Times bestselling author, and a much sought-after guest on the talk show and news circuits with multiple appearances on Ellen, Oprah, Rachael Ray, The View, Dr. Oz, Steve Harvey Show, Wendy Williams, Jimmy Kimmel Live, Good Morning America, Today Show, CNN and the Fox News Channel.
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.
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.
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, but not limited to, the failure of the offering described in this press release to close; Petros Pharmaceuticals’ ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros Pharmaceuticals’ ability to comply with obligations as a public reporting company; the ability of Petros Pharmaceuticals to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act of 2002; the risk that the financial performance of Petros Pharmaceuticals may not be as anticipated by the merger transactions that resulted in Petros Pharmaceuticals’ creation; risks resulting from Petros Pharmaceuticals’ status as an emerging growth company, including that reduced disclosure requirements may make shares of Petros Pharmaceuticals common stock less attractive to investors; 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, such as the Delta variant, 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.
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