Metuchen Pharmaceuticals LLC

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 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 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. View source version on accesswire.com:

NEW YORK , June 22, 2022 /PRNewswire/ -- As per Zion Market Research study, The global erectile dysfunction drugs market reached nearly USD 3.64 billion in 2021 and is projected to expand with a compound annual growth rate (CAGR) of approximately 6.9 percent over the forecast period to grow by about USD 5.94 billion by 2028. Key Industry Insights & Finding of the Erectile Dysfunction Drugs Market Reports: As per the analysis shared by our research analyst, the Erectile Dysfunction Drugs Market is expected to grow annually at a CAGR of around 6.9 % (2022-2028). Through the primary research, it was established that the Erectile Dysfunction Drugs Market was valued approximately USD 3.64 Billion in 2021 and is projected to reach to roughly USD 5.94 Billion by 2028. This is mainly due to the expanding senior population and superior healthcare infrastructure, as per a Rural Health Information Center report released in April 2019 stated that there are more than 46 million older persons in the United States, with that figure predicted to climb to about 90 million by 2050. ED is particularly frequent in men over the age of 40, the rise in the elderly male population is predicted to increase the number of individuals suffering from it. Erectile dysfunction drugs are majorly sold in developed and emerging economies; however, the percentage of their sale is less in low- and middle-income countries. Zion Market Research published the latest report titled as "Erectile Dysfunction Drugs Market By Therapeutics (Existing Drugs, Tadalafil, Sildenafil Citrate Vardenafil, Udenafil, Stendra/Spedra, Lodenafil Carbonate, Mirodenafil Pipeline Drugs, Apomorphine, Alprostadil, Topiglan, Gene Therapy, And Melanocortin Activators), And By Region – Global And Regional Industry Overview, Market Intelligence, Comprehensive Analysis, Historical Data, And Forecasts 2022 – 2028." into their research database. Erectile Dysfunction Drugs Market : Overview Erectile dysfunction is the incapability to attain and maintain a hard erection for sexual activity. Having problems with erection isn't usually a reason for fear. However, if erectile dysfunction is a long-term condition, it can create stress, lower self-esteem, and lead to marital issues. Problems obtaining or maintaining an erection can be a symptom of a more serious underlying health issue, as well as a possible risk for cardiovascular disease. To treat such conditions several drugs are available on the market that can help to maintain the erection during sexual intercourse. With a change in lifestyle and increased stress conditions need for these drugs is on the rise. Get a Free Sample Report with All Related Graphs & Charts (with COVID 19 Impact Analysis): Our Free Sample Report Includes: 2022 Updated Report Introduction, Overview, and In-depth industry analysis COVID-19 Pandemic Outbreak Impact Analysis Included 190 + Pages Research Report (Inclusion of Updated Research) Provide Chapter-wise guidance on Request 2022 Updated Regional Analysis with Graphical Representation of Size, Share & Trends Includes Updated List of tables & figures Updated Report Includes Top Market Players with their Business Strategy, Sales Volume, and Revenue Analysis Zion Market Research methodology Industry Dynamics: Erectile Dysfunction Drugs Market : Growth Drivers Growth in embracing poor lifestyle choices may boost the market growth over the forecast period. With the surge in the adoption of a bad lifestyle, diabetes, obesity, and cardiovascular disease are on the rise, which in turn leads to problems like ED as people become older. The present lifestyle of youth in many emerging countries is very stressful resulting in increased alcoholism, smoking, and fast food or ready-to-eat food consumption. Due to these factors, overall health and fitness are getting compromised which in turn increases the chances of ED. Furthermore, as the senior population grows, so does the number of ED patients, which is a significant driver of the global erectile dysfunction drugs market throughout the projection period. Erectile Dysfunction Drugs Market : Restraints Low awareness and side effects associated with erectile dysfunction drugs may hinder the market growth. Erectile dysfunction drugs are majorly sold in developed and emerging economies; however, the percentage of their sale is less in low- and middle-income countries. This is mainly due to less knowledge about these types of medication, low buying power, and less willingness to adopt such kinds of medications in lifestyle. Furthermore, side effects associated with these drugs such as headache, upset stomach, flushing, nasal congestion, vision problems, dizziness, diarrhea, and rash also contribute to the slow growth of the market. Directly Purchase a Copy of the Report @ Global Erectile Dysfunction Drugs Market : Opportunities Increased pharmaceutical manufacturing in emerging countries is likely to offer better growth opportunities for market expansion. In the last couple of years, major and emerging brands in pharmaceutical industries have increased their investments in emerging countries like India, China, Africa, and major Middle East countries. This has significantly lowered the cost of medicine along with the supply and the distribution of drugs within the countries which is expected to offer significance. Furthermore, increased investments in advertisements are also likely to contribute significantly to the expansion of the global erectile dysfunction drugs market. Global Erectile Dysfunction Drugs Market : Challenges An increase in the availability of counterfeit erectile dysfunction medicines poses a major challenge to the market expansion. The expanding manufacture of generic erectile dysfunction pharmaceuticals, as well as the growing availability of bogus erectile dysfunction drugs, are two important challenges for the market. Consumers typically choose lower-cost generic erectile dysfunction pills over more expensive blockbuster kinds due to the profitable marketing of counterfeit erectile dysfunction drugs at considerably cheaper prices than either patented or generic pharmaceuticals. Aside from that, when patents on blockbuster pharmaceuticals expire, new generic equivalents are entering the market, generally at inexpensive rates. Global Erectile Dysfunction Drugs Market : Segmentation The global erectile dysfunction market is categorized based on therapeutics and region. By therapeutics, the global erectile dysfunction market is bifurcated into Existing drugs, Tadalafil, Sildenafil Citrate Vardenafil, Udenafil, Stendra/Spedra, Lodenafil Carbonate, Mirodenafil Pipeline drugs, Apomorphine, Alprostadil, Topiglan, Gene Therapy, and Melanocortin Activators. Get More Insight before [email protected] : List of Key Players of Erectile Dysfunction Drugs Market : Eli Lilly & Co. Pfizer Dong-A Pharmaceutical Co. Ltd Bayer AG Meda Pharmaceuticals Vivus Inc. Apricus Biosciences. Key questions answered in this report: What are the growth rate forecast and market size for Erectile Dysfunction Drugs Market ? What are the key driving factors propelling the Erectile Dysfunction Drugs Market forward? What are the most important companies in the Erectile Dysfunction Drugs Market Industry? What segments does the Erectile Dysfunction Drugs Market cover? How can I receive a free copy of the Erectile Dysfunction Drugs Market sample report and company profiles? Report Scope: Free Brochure: Recent Developments May 2020, Metuchen Pharmaceuticals, L.L.C., a privately owned biopharmaceutical aimed at defining, developing, gaining, and commercializing revolutionary therapeutics for male sexual health conditions, and Neurotrope, Inc. ("Neurotrope") officially revealed that the two firms have decided to enter into a concise merger agreement within which Metuchen and Neurotrope, Inc. will unite in an all-stock purchase arising in a newly formed partnership firm ("Petros"). Petros is anticipated to become a Nasdaq-listed corporation specializing in men's health. Regional Dominance: North America is projected to lead the global market over the forecast period. North America is likely to dominate the global erectile dysfunction drugs market. This is mainly due to the expanding senior population and superior healthcare infrastructure, as per a Rural Health Information Center report released in April 2019 stated that there are more than 46 million older persons in the United States, with that figure predicted to climb to about 90 million by 2050. When the last of the baby boom cohorts reach 65, the number of older individuals is predicted to climb by roughly 18 million between 2020 and 2030. Because ED is particularly frequent in men over the age of 40, the rise in the elderly male population is predicted to increase the number of individuals suffering from it. The domination of these countries is due to the availability of numerous ED medicines by OTC and internet outlets. The National Institute of Diabetes and Digestive and Kidney Diseases stated roughly 30 million men in the United States suffer from ED. Furthermore, the United States has the greatest rate of self-reported ED. As a result, rising ED prevalence in the US is likely to fuel market growth throughout the projection period. Global Erectile Dysfunction Drugs Market is segmented as follows: Erectile Dysfunction Drugs Market : By Therapeutics Type Outlook (2022-2028) Existing drugs Tadalafil Sildenafil Citrate Vardenafil Udenafil Stendra/Spedra Lodenafil Carbonate Mirodenafil Pipeline drugs Apomorphine Alprostadil Topiglan Gene Therapy Melanocortin Activators Erectile Dysfunction Drugs Market : By Region Outlook (2022-2028) North America The U.S. Canada Europe France The UK Spain Germany Italy Rest of Europe Asia Pacific China Japan India South Korea Southeast Asia Rest of Asia Pacific Latin America Brazil Mexico Rest of Latin America Middle East & Africa GCC South Africa Rest of Middle East & Africa Press Release For Erectile Dysfunction Drugs Market : Browse Other Related Research Reports from Zion Market Research Medical Enzyme Technology Market - Global Industry Analysis : The global Medical Enzyme Technology market accrued earnings worth approximately 4.5(USD Billion) in 2020 and is predicted to gain revenue of about 6.7(USD Billion) by 2028, is set to record a CAGR of nearly 6.2% over the period from 2021 to 2028. 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